This means that new hotels and hospitals will be allowed to go up to height of 70 meters as against the 40 meters that is allowed now. In other words, the new buildings can go up to 22 floors, whereas previously on 12 floors were allowed.

The urban development minister announced this new policy, which stipulates that the buildings that have up to 4 FSI should be constructed next to a 30-metre wide road and should be on a plot that is at least 10,000 square meters in size.

In Gujarat, hospitals and hotels could be constructed only in commercial and residential areas. This new policy enables the builders to go into other areas, with access to wider roads. The policy has come in response to a continued demand from these industries, and is now being supported by the government in their attempt to decongest overcrowded urban areas.

The new policy has also announced that in hospitals and hotels, public areas like basement parking space, refuge area, ramps leading to parking spaces, fire escape, sewage treatment plant, air handling room etc, a per cent of space of the building area will have to be allocated for parking. As of now a standard 30% is the requirement. The policy also allows that hotels can have their swimming pools on any floor, and the new rule an similarly be applied for utilities like laundry, housekeeping, rest rooms etc.

The policy was announced in an official note and stipulates that every hotel must necessarily have a 30 square meter wide yoga room, as a mark of respect for India’s ancient civilization. The changes that the new policy enforces will apply to the eight municipal corporations in the state and the urban development areas attached to them. Corresponding changes need to be made in the general control development regulation (GDCR) rules of each urban body before the new policy can really be enforced. For example, municipalities do not have roads that are 30 meters wide as of now, and this kind of infrastructure will first have to be put in place before the policy will come into action.

Revlimid marketed by Celgene Corporation contains lenalidomide, a derivative of thalidomide.

Besides multiple myeloma, lenalidomide is used in the treatment of the class of hematological disorders known as myelodysplastic syndromes (MDS).

The Hyderabad-based Natco Pharma has filed an abbreviated new drug application (ANDA) with the US FDA for approval to market lenalidomide capsules in 5, 10, 15 and 25 mg strengths.

Sales of lenalidomide (Revlimid) is reportedly growing at 44 per cent compared to last year and the market size of Revlimid is estimated to be around US$1.5 billion in US, according to a Natco release.

Natco Pharma expects to grab 180 days of generic market exclusivity for lenalidomide tablets in 25 mg strength, the release said.

Recently, Natco Pharma launched a low-cost generic versions of Baraclude (entecavir) for the hepatitis B treatment in India.

Baraclude, which contains the anti-viral drug entecavir is developed by Bristol Myers Squibb (BMS).

X-vir is the brand name of Natco Pharma’s entecavir version.

Natco Pharma Limited is one of the fast growing pharmaceutical companies from India. Natco has introduced several first time generic drugs in India. Natco currently ranks as number  1 in terms of revenues from among the Indian companies in the oncological segment.  Natco has US FDA approved manufacturing facilities both for APIs as well as finished dosage pharmaceutical formulations.

Natco recorded a jump in its revenues and profits for the year ended on 31st March, 2009.

Natco registered an increase of 28% in its consolidated revenues, which have gone up to Rs. 465 Crores from Rs. 364 crores.

Natco’s profit after tax, has also gone up to Rs. 4398 lakhs from Rs. 4052 lakhs, recording an increase of 8%. The growth in profits has been lower on account of expenses on Phase I clinical trials of the new chemical entity being developed by the company.

Natco is in the final stages of Phase I clinical trials for its new chemical entity with multiple oncological indications and intends to undertake phase II trials shortly.

Natco’s oncology business recorded a 23% jump in earnings (from Rs. 79 Crores to Rs. 97 Crores) as compared to last year. Natco has made significant inroads in its efforts to introduce its products in European and US markets and this has been reflected in its formulations exports, which have grown (from Rs. 14 Crores to Rs. 31 Crores) by nearly 114% over last year.

Natco has already tied up with Lupin Limited for para IV litigation on Fosrenol (lanthanum carbonate) of Shire PLC and with Dr. Reddy’s Laboratories Limited for a basket of oncology products, apart from Mylan.

Developed by the Korean firm Neurotech Pharmaceuticals Co., Ltd, AAD-2004 has both anti-oxidative and anti-inflammatory activities.

AAD-2004 has a dual function reducing free radicals and PGE2. Oxidative stress resulting from free radicals and PGE 2 are considered causing nerve injury in Alzheimer’s disease, Parkinson’s disease, and amyotrophic lateral sclerosis.

AAD-2004 prevents the progression of Alzheimer’s by cutting down A-beta. Studies in mice showed that AAD-2004 improved cognition besides anti-oxidant and neuroprotective properties in chronic Alzheimer’s disease.

When treated with AAD-2004, ALS-induced mice demonstrated improved motor function. The drug also showed excellent anti-oxidant, anti-nflammatory and neuroprotective activities in mice suffering from chronic ALS disease.

The drug also showed efficacy as neuroprotective agent in Parkinson’s and epilepsy as acute therapy.

Nerotech has completed preclinical studies of AAD-2004 in UK.

The company has begun dosing studies in the Phase 1 clinical testing of the drug AAD-2004, according to a press release.

The Phase 1 study, which is scheduled to begin in April 2010, will evaluate the safety, tolerability, and pharmacokinetics of AAD-2004 in healthy volunteers.

Two initial clinical studies have been completed without serious adverse events to AAD-2004.

Alzheimer’s is a devastating disease that hinders the patient’s ability to remember, learn, perform daily activities and relate to others.

It is generally very difficult to diagnose Alzheimer’s disease.  Doing a postmortem autopsy of the brain is the only way currently available to diagnose the disease.

It is now estimated that every 70 seconds someone develops the condition, according to the Alzheimer’s Association. The association further estimates that about 5.3 million Americans are living with Alzheimer’s.

To arrive at this conclusion, researchers from the Consortium on Safe Labor studied data on cesarean delivery from nearly 229,000 electronic medical records from 19 hospitals throughout the United States.

30.5 percent of all deliveries were done by cesarean section in 2007, they found. Among these 31.2 percent of women underwent cesarean sessions to deliver their first child.

The rate of cesarean delivery went up by more than 50 percent during the decade starting from 1996 to 2007.

“We found that 44 percent of women who attempt vaginal delivery have their labour induced,” stated Dr. Salih Yasin, an associate professor of obstetrics and gynecology at the University of Miami Miller School of Medicine, who is also a senior investigator in the institute’s Division of Epidemiology, Statistics and Prevention Research.

In this labour induced group the the rate of cesarian operation was found double, he noted.

According to him, several women are undergoing cesarean sessions at before they try out normal delivery. These avoidable cesarean surgeries do pose many risks for women.

“First, cesarean section is not just having a baby; it is having a baby through major surgery. So there is a chance of bleeding, infections and longer healing and recovery. You end up having many more cases of cesarean-related hysterectomies and transfusion and maternal death,” he said.

“To make a significant impact on the high cesarean delivery rate in the United States, the focus should be preventing unnecessary primary cesarean deliveries from several aspects,” the researchers wrote.

As a first step, the researchers recommend induced deliveries only in emergencies and cesarian should be avoided in cases of problem birth before the start of labor, especially in first time pregnant women.

Even in cases where a woman had an earlier cesarean, vaginal delivery should be encouraged.

“Finally, increasing access to, and patient education on, trial of labor in women with a previous uterine scar and improving the [delivery] success rate are urgently needed,” the researchers said in the report  published in the Aug. 30 issue of the American Journal of Obstetrics and Gynecology.

Code-named as E5555, atopaxar has been found significantly cutting down deaths from cardiovascular diseases like heart attacks, strokes, studies have shown.

Atopaxar is a protease-activated receptor 1 (PAR-1) inhibitor that targets thrombin-induced platelet activation.
The experimental drug works differently from that of aspirin and other antiplatelet medications such as clopidogrel and ticagrelor.

Eisai has conducted two phase 2 clinical studies on atopaxar. One study involving more that 500 patients with either acute coronary syndrome or high-risk coronary artery disease showed that atopaxar could reduce incidence of heart problems to low levels compared with those on placebo.

Patients taking E5555 in the two Phase II trials demonstrated a numerically lower incidence of heart problems compared with those on placebo but Goto said the overall number of events was very low and the studies were not powered to show efficacy.

One of the trials involved 241 patients with acute coronary syndrome and the other 263 patients with high-risk coronary artery disease.

Atopaxar showed effective blocking platelet aggregation in the studies. Over 90% inhibition of platelet aggregation was achieved with doses of 100 mg and 200 mg while the inhibition rate was 20% to 60% inhibition was achieved with a dose of 50 mg in both study groups.

There was a tendency of increased bleeding incidence with higher dose of atopaxar. The researchers, however, said the dose-dependent trend was numerical and was not statistically significant.

“My personal opinion is that there is no reason not to go ahead with phase 3 trials of this drug,” Dr Shinya Goto, Tokai University School of Medicine, Japan was quoted as saying to Heartwire.

When it comes to the standard dose levels 100 mg per day can be recommended or additional phase 2 studies could be performed testing a dose of 75 mg per day, according to Dr Goto who published the findings simultaneously in the European Heart Journal, and presented in a hot-line session at the European Society of Cardiology 2010 Congress.

NBI-29 is a gold-based, radioactive to be administered as a brachytherapeutic agent. This nanoparticle has been found having very good anti-tumour activities in prostate cancer.

Early studies using NBI-29 nanoparticle drug could also be useful in treating other forms of malignancies including breast cancer, lung cancer, oral cancer besides prostate cancer.

NBI-29 is developed by Nanoparticle Biochem, Inc, a pioneer in the exciting field of nanomedicine which has developing and  out licensed cancer therapy agents.

The Chennai-based Shasun would enter into a 50:50 joint venture with NBI to be known as Shasun NBI LLC to develop the nano medicine, the company said in a press announcement.

`’NBI is excited by the opportunity to join efforts with Shasun Pharmaceuticals in the development of a new nanoparticle-based pharmaceutical drug for use as a prostate cancer therapy agent,” Henry White, CEO of NBI has stated commenting on the collaboration.

5 per cent of NBI stakes is owned by University of Missouri, Colombia. University of Missouri, Colombia is one of the six labs in the USA that are part of the NIH driven ‘Alliance for Nanotechnology in Cancer’, the Shasun release said.

`’The tie-up with NBI and thereby with the University of Missouri at Colombia puts us in a dominant position in the vast expanding and exciting area of nanomedicine. We would have the best minds in nanomedicine working for us and are confident of creating significant Intellectual Property with wide ranging applications in future,” according to Vimal Kumar Shankarlal, managing director of Shasun.

Prostate cancer is the malignancy affecting the prostate gland in men. It is the second leading cancer among men worldwide. Prostate cancer is the sixth leading cause of cancer death in men.

The US$5.2 billion (2008) market for prostate cancer therapies is estimated to grow to USD 7.7 billion by 2015, Shasun release said.

Shasun Chemicals and Drugs has its headquarters in Chennai, Tamilnadu, India. Shasun acquired UK-based Rhodia Pharma through its wholly owned subsidiary Shasun Pharma Solutions Ltd.

Shasun Chemicals & Drugs Ltd posted revenues of Rs. 127 crore, a growth of 5 per cent compared to Q2 FY08  for the quarter ended September 30, 2008. For Q2 FY09, the company suffered forex losses of Rs. 13.50 crore (against Rs. 10.25 crore gain for Q2 last year) resulting in Net Loss of Rs.10.71 crore as against Net Profit of Rs 6.89 crore for the corresponding quarter of last year.

In July, Shasun Chemicals & Drugs Ltd launched its generic version of the recombinant streptokinase in the Indian market.

Shasun developed the biotherapeutic recombinant streptokinase under public-private-partnership. The technology for streptokinase was developed by the Chandigarh-based Institute of Microbial Technology (IMTech), a constituent laboratory of the Council of Scientific and Industrial Research (CSIR).

Streptokinase is used to break up blood clots in the blood vessels of leg veins, lungs and around the heart.

Streptokinase injection can dissolve blood clots that form in the heart, blood vessels, or lungs after a heart attack, or some other disease process.

Shasun has biotech facility at Velacherry, Chennai, southern India The facility is involved in the creation of biotechnology capabilities & capacities especially in the area of protein processing solutions to provide services for the biotech & pharmaceutical companies.

OGX-011 works against prostate cancer by blocking the production of a gene protein called clusterin. Clustering makes malignant prostate cells immune to drug treatments or radiation.

OGX-011 could well be effective in certain other forms of cancers also as the clusterin protein is found in bladder, pancreas, colorectal, ovarian, breast and kidney cancers, researchers hope.

When tested in a patient population involoving 82 men at 12 different cancer centres with conventional prostate cancer treatments such as docetaxel and prednisone for one year, the researchers found that OGX-011 could extend the survival time by as much as seven months.

“The magnitude was much greater than we had expected or hoped for,” he said. “We were hoping for something in the four-month range. That would have been good enough,” Dr. Martin Gleave, executive director of the Prostate Centre at Vancouver General Hospital, who led the team of researchers was quoted as saying in The Vancouver Sun.

Generally, patients with advanced hormone-resistant prostate cancer survive only about 17 to 20 months with chemotherapy and other treatments.

Chemotherapy, however, does not work with advanced prostate cancer. Usually, advanced prostate cancer is treated with hormone therapy. But prostate tumours turn resistant even to hormone therapy, eventually making all the treatment options virtually ineffective.

OGX-011 will now be tested in around 800 patients in a phase 3 trial. The OGX-011 treatment is expected to reach markets in a couple of yeras time.

The U.S. Defence Department has paid $1.4 million for the study. The department is sponsoring numerous prostate cancer trials to help thousands of aging war veterans diagnosed with the disease.

OGX-011 is licensed to OncoGenex Technologies.

Growing at CAGR of 20% per year, Indian biotech industry India will capture roughly 3-5% of the biopharmaceuticals market by 2015.

Among the biotech product categories, the sales of human vaccines have been forecasted to grow by a 10-13% CAGR over the next five years as the market for vaccines shifts from traditional to combination vaccines.

Apart from bulk government orders for combination vaccines from the Central Government under its numerous immunization initiatives, demand for conjugate vaccines in the paediatric and adolescent segment are the drivers of vaccine market growth, according to the report.

Innovative products like bivalent and multivalent vaccines will also spur the rapid growth in this segment by increasing the demand. Shanchol, a bivalent oral vaccine jointly developed by Shantha Biotech and International Vaccine Institute, is an example.

The CII-Yes Bank report on life sciences industry is generally optimistic about the future investments in the biotech sector.

While new business models and products, growing market requirement, private equity investors are expected to augment their interest in the sector, better education and awareness of disease prevention through biopharmaceuticals, rising incomes and government participation will contribute to the steady growth of the industry.

R&D focused Indian biotech companies have the opportunity to enter into alliances through collaborative development projects, the report suggested.  Firm with limited financial resources can partner with larger companies for product development and licensing at an early stage.

Of late, more small and medium companies getting into the discovery process. This increasing number of small and medium players with good science and research background will further fuel the growth of the market as they can be the preferred partners in offshoring activities by pharma companies preferring to outsource various stages of the drug discovery process.

The market for contract research & development to grow at a CAGR of 31% to reach a market size of $ 3 billion by 2015, the report estimates.

Considering India’s unique positioning in biotech sector, the trend of outsourcing various aspects of drug discovery & development could only rise. India’s repute as a low cost destinations may help this trend grow faster.

Domestic market offers huge oppotunities for Indian biotech firms, the report noted.

CH-4051 is the L-isomer of Chelsea’s pipeline drug CH-1504. It is an orally bioavailable, non-metabolized antifolate. CH-4051 has anti-inflammatory, autoimmune and anti-tumor properties that potently inhibit dihydrofolate reductase, an enzyme required for cell proliferation.

CH-4051 has been found safe in preclinical and clinical studies conducted so far. Data from CH-4051 also suggests the experimental drug candidate has superior safety and tolerability, as well as increased efficacy compared to methotrexate, Chelsea Therapeutics said in a press release.

Currently, methotrexate is the leading antifolate treatment and standard of care for diseases including arthritis, psoriasis, Crohn’s disease, ankylosing spondylitis, uveitus, psoriatic arthritis and several forms of cancer.

Chelsea Therapeutics International, Ltd. announced that it received US FDA approval for a phase 2 study to evaluate the efficacy of CH-4051 in rheumatoid arthritis.

Patient screening for CH-4051 phase 2 studies will begin next month.

The multi-national, randomized phase II trial of CH-4051 will involve 250-patients. The double-blind, head-to-head study will compare the efficacy of CH-4051 against methotrexate.

Three daily oral doses of CH-4051 — 0.3 mg, 1.0 mg, 3.0 mg or 3.0 mg –will be tested with or without folate of CH-4051 or 20 mg weekly dose of plus folate supplement for 12 weeks following a two-week methotrexate-washout in patients with rheumatoid arthritis who are experiencing an inadequate response to methotrexate treatment.

“Although MTX [methotrexate] is considered the standard of care in RA, both as a monotherapy and in combination with other RA treatments, the dosing and maximal therapeutic benefit of MTX is limited by well-documented tolerability issues, long-term safety concerns and variable bioavailability,” stated Dr. Simon Pedder, president and CEO of Chelsea Therapeutics.

“Given that CH-4051 is metabolically stable and that all of our preclinical and clinical work suggests enhanced absorption, dramatically increased potency and improved tolerability over MTX, we believe CH-4051 will be safe and highly efficacious in a historically treatment-resistant patient population,” he added.

Chelsea Therapeutics is a biopharmaceuticals development company.

GRC 17536 is a novel chemical entity (NCE) which targets TRPA1 receptor antagonists for pain and respiratory disorders.
A member of Transient Receptor Potential (TRP) family of ion channels, TRPA1 plays a key role in peripheral and central pain signal transmission.

Glenmark has completed preclinical studies of GRC 17536 and is in the process of finishing up phase 1 enabling GLP studies.
The Mumbai-based Glenmark plans to submit the phase 1 application for GRC 17536 in January 2011.

“We are glad to announce our third novel molecule discovery in the TRP space. Both our earlier TRP molecules i.e. TRPV1 and TRPV3 resulted in outlicensing deals for the company. GRC 17536 which is a TRPA1 receptor antagonist is another potential first-in-class globally and we are encouraged by the results shown by the molecule in animal studies. GRC 17536 is highly selective even when compared with other TRPs and can be administered orally,” stated Glenn Saldanha, CEO & managing director, Glenmark.

GRC 17536 is found highly efficacious in treating inflammatory and neuropathic pain in animal models compared to other therapies used currently.

GRC 17536 is more selective than other TRPs and can be taken orally. GRC 17536 could reverse hyperalgesia in animal models of Freund’s complete adjuvant – induced inflammatory and chronic constriction injury (CCI) – induced neuropathic pain with an EC50 of less than 10 mg/kg.

The lead compound also showed promising effect on airway inflammation, bronchoconstriction and cough, Glenmark said in an official release.

GRC 17536 has shown good safety in pharmacology and toxicology studies.

Glenmark has discovered several distinct scaffolds of TRPA1 antagonists with drug-like properties. The Mumbai-based company has filed patent applications for these molecules.

Glenmark has already conducted studies on TRPV1 and TRPV3 receptors.

Glenmark’s molecule for neuropathic pain, osteoarthritis – GRC 10693, was to enter Phase I trials last year. GRC 10693 was Glenmark’s fifth molecule to enter clinical trials.

Glenmark initiated Phase I studies for GBR 500 – a novel biologic molecule – by filing its IND application with the US-FDA, in 2008.

GBR 600, an anti-platelet monoclonal antibody, received approval from MHRA, UK to commence Phase I studies.

In May, Glenmark Pharmaceuticals S.A, a wholly owned subsidiary of Glenmark Pharmaceuticals has entered into an agreement with Sanofi-aventis to grant Sanofi-Aventis a license for the development and commercialization of novel agents to treat chronic pain, the company announced in press release.

Glenmark’s pain drug candidates portfolio consists the new class of agents called vanilloid receptor (TRPV3) antagonist molecules. This includes Glenmark’s first-in-class clinical compound, GRC 15300.

GRC 15300 is currently in phase I clinical development as a potential next-generation treatment for various pain conditions, including diabetic neuropathic pain and osteoarthritic pain.

Under the terms of the agreement, Glenmark will receive an upfront payment of US $20 million, as well as development, regulatory and commercial milestone payments. All such payments could reach a total of U.S. $ 325 million. In addition, Glenmark is eligible
to receive tiered double-digit royalties on sales of products commercialized under the license.

Sanofi-aventis will have exclusive marketing rights for North America, European Union and Japan subject to Glenmark’s right to co-promote the products in the United States and five Eastern European countries.