GlaxoSmithKline has asked that the October batch of H1N1 swine flu Pandemrix be taken out of circulation because it produced serious and immediate anaphylactic reactions in one out of 20,000 vaccinations, compared with one out of 100,000 in other shipments.

Following this, Canada’s H1N1 flu vaccine manufacturer has asked the provinces to temporarily discontinue vaccinating Canadians from a lot of vaccine shipped in October due to a higher risk of adverse reactions, according to Dr. Joel Kettner, Manitoba’s chief public health officer.

“We’ve been asked by the manufacturer GSK to not use this vaccine at this time pending further investigation,” he said.

GlaxoSmithKline has asked several provinces to set aside the 170,000 doses from the questionable batch.

More than 100,000 doses of the H1N1 vaccine are being withdrawn across the country.

GSK said the batch recall is a precaution an they will investigate to see whether there is something wrong with the batch.

“GSK is taking this cautionary action because the Public Health Agency of Canada has received a higher than expected number of reports of anaphylaxis in this lot number compared to other lots,” the company said in a written statement.

One or two allergic reactions are expected in a batch that size. But health officials recorded six severe allergic reactions and alerted GSK, reports said.

However, the anaphylaxis reactions were short-lived and all the patients recovered.

Most of the vaccine Manitoba received from the suspect lot had already been used by the time the province received the alert. Of the 63,000 doses shipped, only 630 remained unused by the four regional health authorities in Manitoba that received them.

About 1,500 doses of the vaccine were sent to Ontario, but officials said none were administered. Officials are now shelving them until the investigation is complete.

The Alberta government has stopped giving out doses from the same batch, although it has  it had not seen any allergic reactions.

GSK’a H1N1 swine flu vaccine Pandemrix batch is being investigated.

Of the 6.6 million doses of H1N1 vaccine given so far to Canadians, there have been 36 serious adverse reactions reported, according to Canada’s chief public health officer, Dr. David Butler-Jones.

Most of the allergic reactions began within minutes of vaccination. Milder side effects, such as nausea, soreness, headaches and fever, have also been seen. Seasonal flu vaccines have been known to cause such reactions every year. All were treated promptly by medical people at the vaccination site.

One person is believed to have died from an anaphylactic reaction following vaccination, but Butler-Jones stressed the death hasn’t been conclusively linked to the flu shot.

What is Pandemrix?
Pandemrix contains parts of influenza (flu) viruses that have been inactivated (killed). Pandemrix contains a flu strain called A/California/7/2009 (H1N1) v-like strain (X-179A).

Pandemrix is given as one dose, injected into the shoulder muscle. A second dose may be given after an interval of at least three weeks. This second dose must be given in children aged from 6 months to 9 years of age.

Pandemrix contains small amounts of haemagglutinins (proteins from the surface) of a virus called A(H1N1)v that is causing the current pandemic. The virus has first been inactivated so that it does not cause any disease.

The most common side effects with Pandemrix (seen with more than 1 in 10 doses of the vaccine) are headache, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection (hardening, swelling, pain and redness), fever and fatigue (tiredness).
The European Commission granted a marketing authorisation valid throughout the EU for the H5N1 mock?up vaccine for Pandemrix to GlaxoSmithKline Biologicals s.a. on 20 May 2008. The marketing authorisation for the H1N1 vaccine was granted on 29 September 2009.

The investigational drug code-named PSD502 combines two local anesthetics – lidocaine and prilocaine – in an aerosol applied to the tip of the penis.

Final stage clinical trial data shows that the spray drug PSD502 delayed orgasm by an average of 108 seconds.

The study involved patients from the USA, Canada and Europe.

The Phase III study was a multi-centre, randomised, double blind, placebo-controlled efficacy study that recruited a total of 540 patients across the two studies.

Patients were treated for a 12-week period with an optional open-label phase of up to nine months.

Analyses of the data show that PSD502 produced a highly clinically and statistically significant increase from baseline in all co-primary study endpoints.

PSD502 increased the intra-vaginal ejaculation latency time (IELT) at least six-fold with PSD502 when compared to baseline.

Patients took PSD502, took an average of 2.6 minutes to reach ejaculation, compared with 0.8 minute for those given a placebo.

There was a five-point difference between PSD502 and placebo in the IPE domains for ejaculatory control and sexual satisfaction, where a two-point difference is considered clinically significant.

There was a 2.5-point difference between PSD502 and placebo in the IPE domain for Distress  where a two-point difference is considered clinically significant.

As a secondary endpoint, partner satisfaction was also found to be considerably greater with PSD502 than placebo.

The incidence of serious adverse events and overall side effects was similar in the PSD502 and placebo group. Overall, PSD502 was well tolerated and there were no systemic adverse events. As previously reported, a very low incidence of mild penile numbing was observed.

“These are highly clinically significant results that show PSD502 is likely to be of considerable benefit to both patient and partner. Particularly pleasing is the ability to take the product on demand,” commented Dr. Ira Sharlip, Clinical Professor of Urology at the University of California at San Francisco and Past-President of the International Society of Sexual Medicine in a company statement.

The rapid onset of action of just five minutes is one of its most attractive characteristics which could be helpful in a big way for men suffering from premature ejaculation, Dr Sharlip added.

Premature ejaculation affects between 25% and 30% of men in the USA and Europe.

There is no effective therapy for premature ejaculation.One current treatment for premature ejaculation consists of topical creams with desensitizing agents which dull the penile skin and delay ejaculation. These creams require use of a condom and/or washing the cream away before intercourse and they may reduce sexual pleasure.

The previously announced Phase III study was conducted entirely in Europe, and its successful outcome was reported in November 2008.

Data from the two studies will be combined for submission for regulatory approval in the USA and Europe.

If approved, the drug would be the first prescription treatment in the United States for premature ejaculation.

Johnson & Johnson said in February that it won approval in Sweden and Finland for the first prescription pill to treat. However, US FDA rejected the drug three years later.

It aims to treat a sexual dysfunction affecting as many as a third of American men aged 18 to 59 years, Shionogi’s Sciele Pharma Inc. unit said in a statement.

In May 2007, Plethora signed an exclusive license agreement with Sciele Pharma, Inc.,  to market PSD502 for premature ejaculation in the USA.In May 2009 Sciele acquired global rights to the product.

Sciele plans to submit the treatment for regulatory review in the first half of 2010.

Sciele Pharma, Inc., a Shionogi Company, is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on the therapeutic areas of Cardiovascular, Diabetes, Women’s Health and Pediatrics.

Headquartered in Atlanta, Georgia, Sciele’s  cardiovascular and diabetes products treat patients with high cholesterol, hypertension, high triglycerides, unstable angina and Type 2 diabetes; its Women’s Health products are designed to improve the health and well-being of women and mothers and their babies; and its Pediatrics products treat allergies, asthma, coughs and colds, and attention deficit and hyperactivity disorder (ADHD).

Shionogi & Co., Ltd., headquartered in Osaka, Japan, is a major research-driven pharmaceutical company dedicated to placing the highest value on patients. Shionogi’s Research and Development currently targets three therapeutic areas: Infectious Diseases, Pain, and Metabolic Syndrome.

Plethora is focused on the development and marketing of products for the treatment of urological disorders. Plethora has products in clinical development for the treatment of overactive bladder (PSD506), stress urinary incontinence (PSD503), interstitial cystitis (PSD597), gynaecological pain (PSD508), erectile dysfunction (PSD510) and premature ejaculation (PSD502). Plethora is headquartered in the UK.

Corifollitropin alfa injection (Elonva) to treat infertility in women developed by MercK & Co is likely to get approval in the European Union countries.

Corifollitropin alfa injection (Elonva) has been recommended for approval by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA), Merck announced in a statement.

Corifollitropin alfa injection (Elonva) is helpful as a treatment in controlled ovarian stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an assisted reproductive technology (ART) program.

If approved by the European Commission, Merck would receive marketing authorization for Corifollitropin alfa injection (Elonva) with unified labeling valid in all European Union Member States.

Corifollitropin alfa injection (Elonva) is the first in the class of sustained follicle stimulants (SFS).

A single subcutaneous injection of the recommended dose of corifollitropin alfa injection (Elonva) may replace the first seven injections of any daily recombinant follicle stimulating hormone (rFSH) preparation in a COS treatment cycle, due to its ability to initiate and sustain multiple follicular growth for an entire week.

“Corifollitropin alfa injection (Elonva) will reduce the burden of injections for women experiencing difficulty conceiving, and the positive opinion is an important step toward a European approval,” said Mirjam Mol-Arts, senior vice president, Merck Research Laboratories.

The Phase III development program for corifollitropin alfa injection (Elonva) included the Engage trial, the largest double-blind fertility agent trial ever performed.

Engage was a non-inferiority trial designed to compare Elonva 150 mcg to 200 IU rFSH. A total of 1,506 patients (with a body weight greater than 60 kg) at 34 in-vitro fertilization (IVF) clinics in North America and Europe were randomized to receive either Corifollitropin alfa injection (Elonva) 150 mcg or a daily dose of 200 IU rFSH, followed by rFSH (maximum 200 IU/day) from stimulation day eight onward, when required.

Starting on stimulation day five, all patients received 0.25mg gonadotropin-releasing hormone (GnRH) antagonist until triggering of final oocyte maturation by human chorionic gonadotropin (hCG). The primary endpoint was the ongoing pregnancy rate assessed at ten weeks or more after embryo transfer.

In the Corifollitropin alfa injection (Elonva) treatment arm the ongoing pregnancy rate (38.9 percent per started cycle) was similar to that achieved in patients receiving a daily dose of rFSH for seven days (38.1 percent per started cycle).(1) The number of oocytes retrieved per attempt, the co-primary endpoint, was 13.7 (plus or minus 8.2) for the corifollitropin alfa injection (Elonva) group and 12.5 (plus or minus 6.7) for the rFSH group.

The ongoing pregnancy rate, the primary endpoint of Engage, in the corifollitropin alfa injection (Elonva) treatment arm (38.9 percent per started cycle) was similar to that achieved in patients receiving a daily dose of rFSH for seven days (38.1 percent per started cycle).

Corifollitropin alfa injection (Elonva)  is designed as sustained follicle stimulant with the same pharmacodynamic profile as rFSH, but with a markedly prolonged duration of FSH activity. Due to its ability to initiate and sustain multiple follicular growth for an entire week, a single subcutaneous injection of the recommended dose of sustained follicle stimulants may replace the first seven injections of any daily rFSH preparation in a COS treatment cycle.

Infertility is a disease or condition that impairs the body’s ability to perform the basic function of reproduction. It is often diagnosed after a couple has not conceived after one year of unprotected, well-timed intercourse. Women over the age of 35 are encouraged to seek diagnosis and treatment for infertility following six months of unprotected intercourse. Around 15 percent of couples of reproductive age have a fertility problem.

There are many causes of infertility including problems with the production of sperm or eggs, with the fallopian tubes or the uterus, endometriosis, frequent miscarriage, as well as hormonal and autoimmune (antibody) disorders in both men and women.

With infertile couples, the source of infertility lies with the male in 40 percent of cases and 40 percent with the female. The remaining 20 percent is either a joint problem or unknown, because the cause has not been identified. There are a variety of treatments available for infertility; these include surgery, hormone treatments, insemination, IVF and natural treatments, among others.

The Nicardipine Hydrochloride Injections, available in strength of 25 mg/10 ml, has an annual sale of about $170 million in the United States.

These injections are used for the short-term treatment of hypertension – or, higher-than-normal blood pressure – when oral therapy is either not feasible or not desirable.

Sun Pharmaceutical Industries Limited was founded in 1983, and listed since 1994.

The company makes as well as markets a large number of pharmaceutical formulations in India, the United States and many other countries across the world as branded generic drugs and generic drugs.

According to a statement from Sun Pharmaceutical Industries Limited, in India, the company is a leader in therapy areas of psychiatry, cardiology, neurology, gastroenterology, orthopedics and diabetology.

The company claims that it has “strong skills” in the spheres of product development, process chemistry, and manufacturing of complex API, and dosage forms.

More information about Sun Pharmaceutical Industries Limited can be had from its website www.sunpharma.com

Hypertension, or high blood pressure, is a chronic medical condition in which the blood pressure rises above normal. It is also referred to, in shortened forms, as HT, HTN, or HPN.

The word ‘hypertension’ normally refers to systemic, arterial hypertension.

Hypertension is usually classified as essential (primary) hypertension, or secondary hypertension.

For essential hypertension, as rule, no medical cause can be found to explain the elevated blood pressure. This is the common form of hypertension, and around 90%-95% of hypertension is essential hypertension.

Secondary hypertension is raised blood pressure which is a result of – that is, secondary to – another condition like kidney disease or tumours.

Continuing hypertension has been found to be one of the risk factors in causing strokes, heart attacks, heart failure, and arterial aneurysm. Also, it is a leading cause of chronic renal failure.

NuvaRing, the vaginal ring, has no side-effects, and is a flexible, transparent ring made of inert plastics, the company claims.

It is a once-a-month vaginal ring which offers the same benefits as the contraceptive pill, plus the advantage of not having to be used daily.

NuvaRing, the first vaginal birth control ring in the world, contains hormones that enter the bloodstream directly, and thus inhibit ovulation.

According to Dr Urvashi Jha, director of the Institute of Obstetrics and Gynaecology, of the Delhi-based Max Healthcare, NuvaRing makes contraception procedure simpler for women.

The ring has to be inserted into the vagina once every week, instead of taking one contraceptive pill each day. This is how it is to be done: Three weeks of insertion, followed by one week of non-insertion interval. This has to be repeated every month for a continued contraceptive effect, Urvashi Jha explains.

The exact positioning of the vaginal ring is not crucial to its functioning.

At the launch of NuvaRing in India, Dr Urvashi Prasad Jha stressed that when a woman uses a contraceptive method that suits her lifestyle, like NuvaRing, she is more likely to be compliant to the regimen, which, in turn, is likely to reduce the risk of unplanned pregnancy. This ease of use further increases its acceptability and usage.

K G Ananthakrishnan, managing director of Organon (India), says that, in India, about 20% of women use contraceptives. NuvaRing, he adds, is good since it does not have any side-effects and does not obstruct any other “routine activity.”

He said the introduction of NuvaRing will increase the contraception options at present available to women in India.

The contraceptive ring, according to Ananthakrishnan, offers the “busy, multi-tasking” Indian women of today “the convenience of a monthly regimen and a self-controlled method” in terms of insertion as well as removal.

The findings of a study conducted in 2007 as well as of a study conducted by market research analysts TNS in 2009 among women in India have shown that one of the main reasons for not using a contraceptive pill or switching from a pill to some other option is the side-effects that regular intake of the pill cause.

According to experts, Indian women may not dislike inserting a contraption in the vagina once a month, and this convenience will result in a higher rate of compliance.

Dr Ignacio Lete, chief of the gynaecological department of Hospital Santiago, Vitoria, Spain, who was present at the launch of NuvaRing, explained that the safety profile of the ring is similar to that of the pills being used now. But, the vaginal ring is basically different from the pill in two ways – one, its way of administration and, two, its frequency of use.

The vagina, according to Dr Lete, is a suitable organ to administer drugs since the organ allows constant hormone levels as has been demonstrated in many scientific studies.

The Oxoferin supply deal has been signed between Dimethaid GmbH, the German subsidiary of Nuvo and Ranbaxy Laboratories Ltd.

Oxoferin is marketed by Dimethaid Gmbh and its partners in parts of Europe, Asia and South America under several trade names including Oxoferin and Oxovasin and it is currently in the process of obtaining marketing approval in Russia.

Under the terms of the agreement, Nuvo will manufacture and supply Oxoferin to Ranbaxy, while the latter will be responsible for obtaining regulatory approval in the licensed territories and has committed to minimum annual purchase quantities once approved.

Oxoferin is a diluted form of Nuvo’s immune modulating drug candidate WF10.

WF10 focuses on supporting the immune system by targeting the macrophage, a type of white blood cell that coordinates much of the immune system, to regulate normal immune function.

In conditions such as Allergic Rhinitis, the body’s immune system inappropriately responds to the presence of foreign allergens.

Research suggests that in some cases, WF10 may rebalance improperly functioning immune systems.

Oxoferin has a positive impact on wound healing leading to contraction, closure and faster healing of wounds. Chronic, hard-to-heal wounds are a serious problem with an increasing incidence, according to Nuvo.

Chronic wounds can be caused by such conditions as burns, pressure sores and poor circulation in the lower extremities. Co-morbid conditions such as diabetes and atherosclerosis reduce blood flow to the extremities and also increase the likelihood of developing chronic wounds such as diabetic foot ulcers and venous ulcers.

The immune system provides an essential defense to micro organisms, cancer and substances it sees as foreign and potentially harmful. WF10 focuses on supporting the immune system by targeting the macrophage, a type of white blood cell that coordinates much of the immune system, to regulate normal immune function.

Nuvo is developing Oxoferin with the support of Development Bank of Saxony in Germany (SAB). Apart from the recently announced support of financial support for Nuvo’s co-operative drug development project with the Fraunhofer Institute of Cell Therapy and Immunology IZI to include pre-clinical and early clinical development of WF10 as a treatment for Rheumatoid Arthritis, the SAB has now announced additional fundings for the research, reveals the Nuvo officials.This support is in addition to the SAB’s financial support for the ongoing pre-clinical and clinical development of WF10 as a treatment for Allergic Rhinitis.

SAB has now committed to provide funding over a three-year period of approximately US$ 3.5 million towards the US$ 6 million estimated cost of these two development projects that are being conducted in Leipzig, Germany by Nuvo Research GmbH, a Nuvo subsidiary.

“These agreements provide further evidence of the potential for WF10,” stated Henrich Guntermann, president and chief executive officer of Nuvo Research. ”

Nuvo is primarily focused on the research and development of drug products delivered to and through the skin using its topical and transdermal drug delivery technologies.

Nuvo’s lead product is Pennsaid, a topic

Potentox is the third product of Venus Remedies being granted Companies and Intellectual Property Registration Office (CIPRO) in South Africa after Sulbactomax and Tobracef.

CIPRO’s also also the third patent of Potentox within five months of its first grant in South Korea.

Potentox has potential to reduce the toxicity caused by aminoglycosides and disease condition.WHO data suggest that there are 4.50 million cases of pneumonia, are a leading cause of death and years of life last in South Africa.Pneumonia is fifth leading cause of death in females and seventh major cause of mortality in males.

In Sub-Saharan Africa among HIV-infected patients presenting with a lower respiratory tract infection have confirmed that community-acquired pneumonia is the second cause of death with incidence of pneumonia due to S. pneumonae rising to 34.5 per cent.

In South Africa currently 8 per cent gross domestic product (GDP) is spent on health and more than half of the is amount is channelled into medical insurance schemes that serve the indicates that there is huge gap in demand and supply keeping in view the mortality in African continent.

Venus expects to fetch good share in its kitty by out licensing and selling Potentox in African continent.

Chandigarh-based Venus Remedies has received an Indian patent for its cephalosporin and aminoglycoside combination injectable product Potentox in September.

Potentox patent was first of its kind in India as this is first product patent granted Indian Patent Office for a fixed dose combination (FDC) injectable, after the country ussured in the new IP regime on 1st of January 2005, Venus Remedies said in a press statement.

Venus Medicine Research Centre (VMRC) studied the resistance pattern of pneumonia causing bacteria with existing therapies, reason of failures in order to find this innovative drug combination Potentox, the release said.

Venus Remedies launched Potentox in Indian market two years back.

Potentox was launched in Indian market on gaining DCGI approva after submitting the data from preclinical and multicentric phase-III clinical trials on more than 300 patients. Potentox has already been used by more than 20,000 patients across India.

Post marketing phase IV studies were also conducted to re-establish the safety of Potentox.

In August, Venus Remedies got another Product Patent for Tobracef from the Companies and Intellectual Property Registration Office (CIPRO), South Africa. Tobracef, which is indicated for the treatment of complicated mixed bacterial infection of acute pulmonary exacerbations, cystic fibrosis, chronic obstructive pulmonary disease, an FDC cephalosporin and aminoglycoside.

Tobracef was launched in July 2008. Tobracef is under process of registration in many regulated and semi – regulated markets.

Venus Remedies India has two manufacturing locations in India and one in Germany. Venus is a contract manufacturer of oncological and cefelosporine injectable products following EU-GMP norms.

US Food and Drug Administration has approved Matrix’Abbreviated New Drug Application (ANDA) for lansoprazole delayed-release capsules in 15 mg and 30 mg strengths, the company said in a press release.

Matrix Laboratories will commence marketing of lansoprazole immediately and will be sold under the Mylan Pharmaceuticals brand.

Lansoprazole delayed-release capsules product had US sales of approximately US$ 3 billion for the 12 months ending June 30, according to IMS Health.

Currently, Mylan has 125 ANDAs pending FDA approval representing US$ 84.1 billion in annual brand sales, according to IMS Health.

Thirty-seven of Mylan’s pending ANDAs are potential first-to-file opportunities, representing US$ 19.2 billion in annual brand sales, for the 12 months ending June 30, according to IMS Health.

Matrix Lab received tentative approval under the President’s Emergency Plan for AIDS Relief (PEPFAR) in September for a fixed-dose combination (FDC) of efavirenz, emtricitabine, tenofovir disoproxil fumarate tablets, 600 mg/200 mg/300 mg.

Matrix Lab’s efavirenz, emtricitabine and tenofovir combination pill is the generic version of Gilead Sciences’ Atripla tablets.

Atripla is indicated for the treatment of HIV-1 infection in adults.

Single combination pills containing several drugs into a once daily dose can dramatically reduce pill burden, and improve patient compliance with complex AIDS treatment regimens.

In 2007, Matrix signed an agreement with the Clinton HIV/AIDS Initiative (CHAI) that significantly lowers the price of AIDS treatment for second-line anti-retroviral drugs (ARVs), as well as a new, once-a-day pill that is currently cost prohibitive in the developing world.

This deal made Matrix one of the key suppliers of affordable second-line Antiretroviral (ARV) drugs into 66 low- and middle-income countries in Africa, Asia, Latin America and the Caribbean. Second-line treatment is required in patients who develop resistance to first-line treatment and typically costs 10 times the price of first-line therapy. Nearly half a million patients will require these drugs by 2010.

Approximately 30% of HIV/AIDS patients in developing countries depend on at least one Matrix ARV product.

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to more than 140 countries and territories.

Mylan Matrix, which runs a specialty business focused on respiratory and allergy therapies, is the world’s third largest active pharmaceutical ingredient manufacturer.

Matrix Laboratories has API manufacturing facilities at four locations in and around Hyderabad and Visakhapatnam, India. Matrix Lab’s solid oral dosage forms facility is located near Nashik, about 150 km from Mumbai. All of Matrix Lab’s facilities are USFDA approved. The facilities also have ISO 9000, ISO 14000 Certifications.

Flibanserin, a pill arouse sexual desire in women by Boehringer Ingelheim GmbH, is currently underway.

Flibanserin, whose phase 3 data will be presented this week at a meeting on sexual disorders in Lyon, is being watched as female Viagra with the potential to revolutionize the treatment of the rather complex medical condition of decreased sexual libido in women.

Flibanserin, however, addresses sexual desire problem in women by working in the libido boosting mechanics of the brain, unlike Viagra which helps driving more bloodlow to men’s penile area leading to erection.

Flibanserin is non-hormonal oral daily treatment for pre-menopausal women suffering from Hypoactive Sexual Desire Disorder (HSDD).

Flibanserin works on the central nervous system and acts as a 5-HT1A serotonin receptor agonist and 5-HT2A serotonin receptor antagonist.

Boehringer Ingelheim is investigating flibanserin as a potential treatment for women with Hypoactive Sexual Desire Disorder (HSDD), a condition characterized as suffering from decreased sexual desire.

Boehringer Ingelheim is currently conducting several large Phase III clinical trials evaluating flibanserin in over 5,000 women at 360 locations in the USA, Canada and Europe.

The trials – The Bouquet Studies – are expected to be completed in 2008/09. They will provide a greater understanding of flibanserin’s potential to treat HSDD in pre-menopausal women.

Boehringer Ingelheim’s is running  a group of phase III clinical trials called `Bouquet Study` programme.

The Bouquet Studies comprise seven trials including ROSE, DAHLIA, VIOLET, DAISY, ORCHID, SUNFLOWER and MAGNOLIA and are being conducted by Boehringer Ingelheim in North America and Europe involving over 5,000 pre-menopausal women.

The Bouquet Studies aim to demonstrate the efficacy and safety of flibanserin to support regulatory approval of flibanserin to treat this common and distressing condition.

Endpoints for flibanserin trials are based on guidance received from US FDA and include measuring increases in the level of sexual desire, decreases in distress related to low desire, as well as the number of `satisfying sexual events`.

Up to one in ten women are suffering from a condition called hypoactive sexual desire disorder (HSDD) with only a third of these seeking advice or help from their healthcare professional, data from American College of Obstetricians and Gynaecologists (ACOG) annual clinical meeting suggest.

HSDD is a highly prevalent, yet under-diagnosed, medical condition that can have a serious, detrimental effect on women’s quality of life, causing significant psychological distress and negatively impacting their relationships with their partners.

HSDD is a type of female sexual dysfunction, defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) of the American Psychiatric Association, as diminished feelings of sexual interest or desire, absent sexual thoughts or fantasies and lack of responsive desire that causes marked distress or interpersonal difficulties and is not caused by a medical condition or drug.

Neurotransmitters in the brain and sex hormones both play a role in normal sexual function. The brain is central to sexual response and while hormonal treatments may be of benefit to some women who suffer from HSDD, for example those women who have had a surgical menopause through ovarectomy (removal of the ovaries), this is by no means the complete answer for the many millions of women experiencing HSDD.

“Flibanserin is currently being researched for its potential to help the many women suffering from HSDD. In my everyday practice I have seen many women with this condition for whom this may mean hope as they search for help”, said lead study investigator Dr Evan Goldfischer.

If approved, flibanserin could become one of those very few drugs currently available to treat declining sexual libido in women in the US market.

The market for medicines to rekindle female libido could be bigger than the $2 billion a year in U.S. sales.

The only female sexual dysfunction therapy approved in the U.S. is Eros-CTD, from NuGyn, Inc., a suction pump that fits over the clitoris.

Intrinsa, a testosterone patch from Noven Pharmaceuticals Inc. licensed by Procter & Gamble, is sold in Europe for women whose uteruses have been removed.

Intrinsa approval is put on hold in US in 2004 on concerns of safety.

Procter & Gamble’s patch,  LibiGel, a testosterone gel from BioSante and bremelanotide, an injected therapy from Palatin Technologies are othe other potential therapies for dicreased female libido currenly under development.

Headquartered in Ingelheim, Germany, Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies.

With the inclusion of Indinavir, Ranbaxy now has a total of 19 ARVs on the WHO pre-qualification list.

Ranbaxy’s ARVs, including the recently approved WHO pre-qualified products, are manufactured at the company’s state-of-the-art manufacturing facilities.

Ranbaxy has been providing ARV medicines in over 70 markets worldwide.

Ranbaxy’s ARVs have been used as mainstays in various large treatment programs, both National and NGO/Institutional.

ARV medicine produced by Ranbaxy are used by over 400000 patients worldwide , in various developing and underdeveloped countries.

Indian generic maker Cipla Ltd’s  version of Roche’s oseltamivir (Tamiflu) has been included in WHO’s prequalification list, in May.

WHO’s Prequalification Programme aims to make quality priority medicines available for the benefit of those in need. WHO achieves this through its evaluation and inspection activities, and by building national capacity for sustainable manufacturing and monitoring of quality medicines.

WHO’s strategy for pre-qualified drugs includes: applying unified standards of acceptable quality, safety and efficacy; evaluating the quality, safety and efficacy of medicinal products, based on information submitted by the manufacturers, and inspection of the corresponding manufacturing and clinical sites; prequalifying quality control laboratories of pharmaceuticals and build the capacity of staff from national regulatory authorities, quality control laboratories, and from manufacturers or other private companies, to ensure medicines quality.

WHO’s list of prequalified medicinal products used for HIV/AIDS, malaria, tuberculosis and for reproductive health produced by the Programme is used principally by United Nations agencies — including UNAIDS and UNICEF — to guide their procurement decisions.

WHO’s prequalified medicines list has become a vital tool for any agency or organization involved in bulk purchasing of medicines, be this at country level, or at international level, as demonstrated by the Global Fund to Fight AIDS, Tuberculosis and Malaria.

Daiichi-controlled Ranbaxy Laboratories Ltd has posted a third-quarter profit before tax at USD 33 Mn (Rs. 1,601 Mn) with an EBITDA margin of 13% to sales for the quarter ending on September 30, boosted by earnings fro emerging market sales including India and South Africa.

Net income was 1.17 billion rupees ($25 million) compared with a year-earlier loss of 3.95 billion rupees.

Sales in India, South Africa and other emerging markets contributed for 62 percent of Ranbaxy’s revenue.

Developed markets de-grew by 30%, primarily on account of loss of sales in USA because of the import alert and Application Integrity Policy imposed by the USFDA.

North American region recorded sales of USD 61 Mn (Rs. 2,955 Mn) during the quarter, a de-growth of 43%.

In USA, sales during the quarter were USD 44 Mn (Rs. 2,138 Mn), a de-growth of 53% over Q3’08. This was primarily on account of ongoing USFDA issues and the discontinuation of omeprazole authorized generic.