Contract research news in brief

Outsourcing-Pharma.com rounds up recent developments among contract research organisations, including WuXi PharmaTech, AMRI, Physiomics, Biofocus and Metabolon.

Private equity firm Warburg Pincus has taken a 5.4 per cent stake in China's WuXi PharmaTech, which recently withdrew from plans for a public offering of up to 10.1m American depositary shares.
"Warburg Pincus not only will strengthen our investor base, but more importantly we believe that it will provide strategic and business assistance to us," said WuXi's chief executive, Ge Li.
Albany Molecular Research Inc (AMRI) says it has more than doubled the capacity of its Science Park III facility in Singapore with a 10,000 square foot laboratory expansion for its medicinal chemistry unit and the opening of an in vitro biology lab.
The in vitro biology group will test compounds synthesized by the chemistry teams and deliver potency data using cell-based or biochemical assays, allowing the firm to carry out complex drug discovery projects in a shorter time.
AMRI said it expects to hire at least 70 additional chemists and biologists to staff the Singapore facility over the next three years to meet increasing demand.
The US National Institutes of Health (NIH) have extended their agreement with Galapagos' service division BioFocus DPI for the operation of the Molecular Libraries Small Molecule Repository (MLSMR) until December 2010.
The MLSMR acquires and stores compounds under the contract with NIH and distributes these compounds for high-throughput biological screening throughout the NIH's academic network in the US.
According to the terms of this agreement, Galapagos will receive more than $9m (€5.7m) over the course of the two-year extension.

Systems biology specialist Physiomics has been contracted to perform two new cancer-related research projects for Eli Lilly, after a successful collaboration earlier this year in a study of cancer cellular processes for drugs targeting the cell cycle.
UK-based Physiomics will perform two new projects for in silico simulations in the field of oncology for Lilly. The first has the aim of finding a way to identify patients who are likely to respond to an unnamed Lilly drug, while the second will investigate the mechanistic link between various biomarkers and certain other Lilly compounds.

Metabolon has expanded its multi-study agreement with Mitsubishi Tanabe Pharma, giving the latter 'preferred' access to its biochemical profiling services, and forged new collaborations with Pfizer and the University of Texas. Metabolon's platform technology is used to analyse biological samples for the discovery of markers and pathways associated with drug action and disease.
Mitsubishi Tanabe has committed several upcoming research studies to Metabolon, and the two companies say they are in the process of publishing joint study results in peer-reviewed publications. Meanwhile, Pfizer is tapping the company's metabolomics platform for its bioprocess division, and will use it to try to optimise bioprocesses and reduce manufacturing costs. The agreement with the University of Texas will focus on finding new biomarkers relating to diabetes.
CeeTox, a CRO based at Michigan University's Business Technology and Research Park, has been awarded state-funding of $150,000 in order to hire Pfizer staff that lost their jobs when the multinational shut down some of its R&D functions in Kalamazoo, Michigan, last year. Ceetox, which tests the toxicity of potential new drugs, has agreed to hire three former Pfizer scientists. Two other companies in the area have agreed to similar deals.
Synomics Pharmaceutical Services, a US CRO which provides bioanalytical, stability and analytical testing services for the pharmaceutical industry, has cleared an inspection of its facilities and operations in Wareham, Massachusetts, by the Food and Drug Administration (FDA).

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Torrent Pharm posts lower net of Rs.76.91 cr in Q3

Torrent Pharmaceuticals has suffered minor set back in profits during the third quarter ended December 2010 on account of higher R&D expenditure, employees cost and raw material costs. Further, investment in expansion in domestic and international market and adverse currency movements also impacted profits. Its consolidated net profit declined by 7.3 per cent to Rs.76.91 crore from Rs.82.95 crore in the similar period of last year. Its net sales, however, increased by 19.5 per cent to Rs.554.82 crore from Rs.464.20 crore. With margins under pressure, its earnings per share declined to Rs.9.09 from Rs.9.80 in the last period.

The company's R&D expenditure went up by 24.3 per cent to Rs.34.79 crore from 28 crore and its employees cost increased by 27.8 per cent to Rs.97.92 crore from Rs.76.64 crore. The EBDITA saw a nominal growth of 4.6 per cent to Rs.116.81 core from Rs.111.73 crore.

During the third quarter, its domestic formulation business recorded sales of Rs.214 crore, growing 17 per cent. Sales outside India jumped by 19 per cent to Rs.292 crore. Operations in Brazil registered impressive performance with sales growth of 15 per cent and revenues moving up from Rs.89 crore to Rs.102 crore. Germany-based Heumann operations recorded sales of Rs.76 crore with growth of 15 per cent. Europe (other than Heumann), Russia and CIS and Rest of he world operations grew by 22 per cent with sales
of Rs.78 crore rising from Rs.64 crore in comparable quarter. This company has recently entered the
Mexico and has plans to enter UK & Romania markets shortly.

For the first nine months of 2010-11, Torrent Pharma's net sales increased by 18 per cent to Rs.1662 crore from Rs.1411 crore in the same period of last year. Its domestic sales moved by 19 per cent to Rs.840 crore. The net profit increased sharply by 32 per cent to Rs.227 crore against Rs.172 crore in the last period.

The construction activities commenced at Dahej SEZ, where the company is setting up facilities for manufacture of API and formulations.

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Peregrine initiates Investigator-Sponsored Trial in HER2-negative metastatic breast cancer

Peregrine Pharmaceuticals, Inc. a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, announced the initiation of an Investigator-Sponsored Trial (IST) for patients with HER2-negative metastatic breast cancer, which accounts for 75% of metastatic breast cancers. This open-label phase I trial will treat patients with Peregrine's investigational monoclonal antibody bavituximab in combination with the chemotherapy agent paclitaxel.

“Bavituximab combined with chemotherapeutic agents has shown promising anti-tumour activity in two phase II breast cancer clinical trials and has repeatedly demonstrated synergistic anti-tumour activity in preclinical models,” said Alison Stopeck, MD, lead investigator of this trial and director of the clinical breast cancer program at the Arizona Cancer Centre at UMC North. “This safety study will also examine the role of cell-specific micro-particles, potentially providing novel insights into biomarkers that may correlate with a patient's response to therapy and ultimate prognosis.”

Currently, Peregrine's bavituximab is being evaluated in randomized phase II trials in front-line Non-Small Cell Lung Cancer (NSCLC), second-line NSCLC, pancreatic cancer, and HCV. Peregrine's first IST, a phase I/II trial in hepatocellular carcinoma, was initiated last month and additional studies are being planned.

“Our two signal-seeking phase II breast cancer trials combining bavituximab with taxane-based chemotherapy regimens showed promising tumour response and progression-free survival,” said Joseph S. Shan, vice president, clinical and regulatory affairs at Peregrine Pharmaceuticals. “We are delighted to support Dr Stopeck and her team as they elucidate the potential mechanisms behind the enhanced anti-tumour activity.”

In this phase I single-arm, open-label trial, up to 14 patients with HER2-negative metastatic breast cancer will be treated with paclitaxel (80 mg/m(2)) weekly for three weeks out of each four-week cycle and bavituximab (3 mg/kg) weekly. Patients will be treated until disease progression or intolerable toxicity. The primary endpoint is to determine the safety, feasibility, and tolerability of combining paclitaxel with weekly bavituximab therapy. Secondary endpoints include pharmacodynamics and coagulation marker changes. Patients will also be assessed for objective overall response rate and median Progression Free Survival (PFS) according to RECIST criteria.

Peregrine's IST programme offers oncologists the opportunity to conduct clinical trials with bavituximab.

The World Health Organization reports that breast cancer is the most commonly diagnosed cancer in women and is second only to lung cancer as a leading cause of female cancer deaths. The National Cancer Institute estimates that approximately 192,370 US women will be diagnosed with breast cancer in 2009 and 40,170 women will die of the disease in the US alone. HER2-negative accounts for approximately 75% of metastatic breast cancers.

Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral infections.

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INTERPHEX 2011 to be held from March 29 to 31 in New York

INTERPHEX 2011,  world's leading forum for pharmaceutical manufacturing will be held at Jacob K. Javits Convention Center, New York from March 29 to March 31, 2011.

INTERPHEX addresses technology solutions and education for all aspects of drug manufacturing, from process development through delivery to market. This annual event  comprises four major segments: Facilities, Outsourcing & Contract Services, Information Technology and Manufacturing/Processing.

The INTERPHEX conference will feature two days of comprehensive educational opportunities to reflect the trends and challenges facing pharmaceutical and biopharmaceutical professionals today.

It is the  only meeting place where intelligence and passion intersect with the full spectrum of drug production products and services to create innovative solutions that improve manufacturing and supply chain performance for pharmaceutical, biologic, generic and service provider professionals.

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Wockhardt launches generic version of Protonix tablets in US

Wockhardt has received final approval from the US FDA for marketing 20mg and 40 mg pantoprazole delayed release tablets of pantoprazole (Protonix) that is used for treatment of GI ulcers and hyperacidity. Pantoprazole is the generic name for the brand Protonix marketed in the US by Pfizer. As the patent covering this product expired on January 19, 2011. Wockhardt launched the product immediately.

According to Wolters Kluwer, the total market for this product in the US is about $2 billion and belongs to the class of proton pump inhibitors. The product is a delayed release tablet and requires specialized technology and manufacturing capability.

Habil Khorakiwala, chairman, said, “This is yet another product that Wockhardt has been able to launch on the date of patent expiry. The ability to launch products on the date of patent expiry is a critical requirement to create maximum value and over the years. Wockhardt has been able to reinforce this capability on several occasions.”

The tablet will be manufactured at the US FDA certified formulation plant at Waluj, Aurangabad and the Pantoprazole sodium API will be manufactured in the FDA certified API plant at Ankleshwar, Gujarat. The tablets and the API were developed in-house.

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Adventrx Pharma receives PDUFA date for Exelbine NDA

Adventrx Pharmaceuticals, Inc. announced that the US Food and Drug Administration (FDA) has established a Prescription Drug User Fee Act (PDUFA) date of September 1, 2011 for the review of the Exelbine (ANX-530) New Drug Application (NDA). The acceptance of the Exelbine NDA is the FDA's determination that the application is sufficiently complete to permit a substantive review, and the PDUFA date is the goal date for the FDA to complete its review of the NDA.

“With a September PDUFA date established in the day 74 letter from the FDA, we look forward to working closely with the Agency on moving Exelbine toward approval this year,” said Brian M. Culley, chief executive officer of Adventrx.

Adventrx is seeking approval of Exelbine for the same indications as Navelbine, a branded formulation of vinorelbine, including non-small cell lung cancer. Adventrx submitted the NDA as a 505(b)(2) application that relies in part on the FDA's findings of safety and effectiveness of a reference drug. The Exelbine NDA includes data from one clinical bioequivalence study designed to assess the pharmacokinetic equivalence of Exelbine and Navelbine, the reference drug. In this clinical bioequivalence study, Exelbine and the reference drug were determined by Adventrx to be bioequivalent.

Adventrx retains exclusive worldwide rights to Exelbine, other than in South Korea, China, Hong Kong, Macau and Taiwan. In March 2010, the FDA conditionally accepted “Exelbine” as the proposed proprietary name for ANX-530. The United States Patent and Trademark Office has allowed patent claims related to Exelbine, which claims issued in January 2011 and will expire in November 2027.

Adventrx Pharmaceuticals is a specialty pharmaceutical company whose product candidates are being developed to improve the performance of existing anti-cancer drugs by addressing limitations associated principally with their safety and use.

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Indian Academy of Sciences confers fellowship on IICT scientist

The Indian Academy of Sciences (IAS), Bangalore has conferred fellowship on Dr Srivari Chandrasekhar, a scientist of the Indian Institute of Chemical Technology (IICT), Hyderabad.

Dr Chandrasekhar's contribution is in the field of organic chemistry and medicinal chemistry, which helped in solving fundamental problems in developing new reactions and also addressed the environmental issues.  His major contributions include synthesis of complex natural products, especially of marine origin with anti-cancer and anti depressant properties, green chemistry and automation chemistry to make large number of new chemicals. He has published more than 200 papers in international journals. He has also solved several problems in process chemistry for the pharmaceutical industry. He is also a fellow of National Academy of Sciences.

The IAS is one of the oldest and prestigious academies of the country which honour distinguished scientists of the country in all branches of science and was started by Prof C V Raman.

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ADMA wants Dept of Ayush to enhance subsidy provided under scheme nos 4, 5

The Ayurvedic Drug Manufacturers' Association (ADMA) wants the Department of Ayush to increase the subsidy provided under scheme no 4 and 5 to 50 per cent so that the Ayurveda, Siddha & Unani (ASU) drug
manufacturers can utilise the scheme for the benefit of the industry. As of now, scheme no 4 and 5 provides only 30 per cent subsidy i.e. upto 30 lakh towards upgrading quality control facilities which is very low. Moreover the subsidy is available only for one scheme at a time which is not industry friendly.
This centrally sponsored scheme is provided for the ASU manufacturers of the country so that they can improve and upgrade their Quality Control (QC) and manufacturing facilities with the government support. Scheme no 4 deals with provision regarding assistance to ASU drug manufacturing units to establish an
in-house quality control laboratory for the purpose of QC testing of all raw materials or finished products as per pharmacopoeial parameters including testing of ingredients heavy metals, pesticide residue, microbial load etc. Whereas scheme no 5 deals with assistance to ASU manufacturing units having a turnover of upto Rs.20.00 crore for acquiring US FDA/EU good manufacturing practices certification for their units.
Chandrakanth Bhanushali, general secretary, ADMA, points out, “Though the vision of the Department is very commendable its not proving to be very effective as of now. Mainly because the subsidy provided by the government which is just 30 per cent i.e. upto 30 lakh towards upgrading quality control facilities and manufacturing facility is very low compared to the demand. The minimum requirement to reach the GMP is almost one crore, so how will it be possible for a small scale or micro level ASU manufacturer whose annual turn over is not more than Rs.25 lakh per annum to benefit with just 30 per cent of subsidy.”
Other major problem faced by the ASU manufacturers is that the scheme provides 30 per cent subsidy only for one scheme at a time. Which means that the ASU manufactures will get subsidy for only one scheme whereas he will have to invest money from his own pocket for the other scheme which is quite high and out of reach for many ASU manufacturers.
“We would request the government to make certain changes in this matter for the betterment of the industry. We want the government to amend the subsidy to 50 per cent for each scheme as well as ensure the availability of soft loans from banks for the up gradation process,” Bhanushali expressed.
This is not an ADMA recommendation alone. In fact it has been earlier referred in the planning commission's XIth. plan steering committee report for the AYUSH sector as well. He clarified. “We are at the fag end of the XIth plan and are yet to partake in the fruits of promised plan proposals.”

Further he pointed out that this schemes should also be extended for clinical trials and new entrepreneurs. Clinical trials expenditure goes to minimum of Rs.5 lakh, depending upon the protocol of the product and the institution conducting the trial, so if this scheme is extended here it will be a great boost for the industry.
Whereas if this scheme is extended for new entrepreneur who wants to enter in the manufacturing of ASU medicines as per WHO GMP or as per Ayush Premium Mark he will be not facing any funding problems and thus will also act as a model for others.

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Govt constitutes Evaluation Committee to screen & approve applications for stem cell therapy

Union government has constituted a Cellular-based Biological Therapeutic Drug Evaluation Committee to screen and approve applications submitted for the stem cell therapy. The committee is headed by Dr VM Katoch, secretary, department of health research, ministry of health and family welfare and director-general, Indian Council of Medical Research (ICMR).

The formation of the Committee will now help to handle the issues on stem cell applications for a host of therapies. It will also oversee the assessment of standardization of methods for isolation, culture, storage of stem cells, development of standard operating procedures, process validation, inspection of controlled Good Manufacturing Practice (GMP) infrastructure, monitoring the delivery of stem cells and safe use of and data entry among others.

The Cellular-based Biological Therapeutic Drug Evaluation Committee will now formally approve all the stem cell projects for clinical applications. Final stem cell guidelines are not yet through. The ICMR and DCGI have asked for comments on the draft guidelines from the industry and research centres which have been provided. Now the two regulatory authorities are expected to finalize the same and place it for clearance from Parliament.

“The formation of the new committee is a step in the right direction and it will also look into the legal aspects. The committee will meet in the first week of February to look at our submissions to seek the clearance for phase II b and phase III studies for critical limbs ischemia,” stated BN Manohar, president, Stempeutics.

Stempeutics has now carried out animal studies in association with the National Institute of Nutrition Hyderabad to carry out the safety and toxicology studies for its product Stempeucel. The product has completed the pre-clinical studies. Now the company has applied to the Drugs Control General of India (DCGI) for the permission to carry out phase II b and phase III trial.

ICMR is the technical and clinical committee but all formal clearances for the human studies will come in from the Drugs Control General of India. While the Department of Bio-Technology (DBT) promotes the science of stem cells and encourages research, the DCGI has been looking at ways for the commercialization of stem cell autologous and allogenic therapies, he added.

Overall stem cells is a promising field but it is quite clear now that there are evidently no shortcuts. Therefore a marathon effort is needed to arrive at the final product. The researchers are looking to upscale the product to the clinical phase need to define the product, indicate the formulation process in detail and systematically maintain all data right from processing to product development. Stem cells can be produced only in controlled Good Manufacturing Practice (GMP) facility to ensure the production of a high quality efficacious product, stated Manohar.

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Novo Nordisk, Emisphere enter licence agreement to develop oral formulation of insulin for diabetes

Emisphere Technologies, Inc. and Novo Nordisk A/S announced that they have entered into an exclusive Development and Licence Agreement to develop and commercialise oral formulations of Novo Nordisk’s insulins, which have the potential of treating diabetes, using Emisphere’s Eligen Technology. This is the second licence agreement between the two companies. The first agreement for the development of oral formulations of GLP-1 receptor agonists was signed in June 2008 with a potential drug currently in a phase 1 clinical trial.

The insulin agreement includes 57.5 million US dollars in potential product development and sales milestone payments to Emisphere, of which 5 million dollars will be payable upon signing, as well as royalties on sales. Further financial details of the agreement were not made public.

“This is an encouraging agreement on a promising technology for oral administration of proteins. We are delighted to continue working with Emisphere and their Eligen Technology. It fits very well with Novo Nordisk’s strategy within diabetes research,” said Peter Kurtzhals, senior vice president, Diabetes Research Unit at Novo Nordisk.

This extended partnership with Novo Nordisk is important for Emisphere for several reasons, said Michael V. Novinski, president and chief executive officer of Emisphere. “To date, our collaboration with Novo Nordisk has been very productive, and today’s agreement has the potential to offer significant new solutions to millions of people with diabetes worldwide. Finally, it also serves to further validate our Eligen Technology”.

Emisphere’s broad-based drug delivery technology platform, known as the Eligen Technology, uses proprietary, synthetic chemical compounds, known as Emisphere delivery agents, sometimes called carriers. Emisphere’s Eligen Technology makes it possible to deliver a therapeutic molecule without altering its chemical form or biological integrity.

Novo Nordisk is a global healthcare company and has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy.

Emisphere is a biopharmaceutical company that focuses on the unique and improved delivery of therapeutic molecules or nutritional supplements using its proprietary Eligen Technology.

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Mylan's Matrix gets tentative US FDA nod under PEPFAR for Lamivudine & Zidovudine tabs

 Mylan Inc. announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the US Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Lamivudine and Zidovudine tablets, 30 mg/60 mg. The NDA is based on the reference listed drug Combivir, by ViiV Healthcare. This innovative paediatric fixed-dose combination (FDC) in tablet form was developed by Matrix for use in treating children with HIV/AIDS. This product will be eligible for purchase outside the U.S. in certain developing countries.

Mylan president Heather Bresch said: "The approval of Lamivudine and Zidovudine is particularly important because it makes available an innovative FDC treatment option for children who are living with HIV/AIDS in developing countries. The addition of this product to our ARV franchise is a critical next step in helping to extend and improve the quality of life of people living with HIV/AIDS and to continue to expand access to high quality, affordable ARVs."

Lamivudine and Zidovudine tablets, a combination of two nucleoside analogue reverse transcriptase inhibitors, are used in combination with other medications to control HIV infection. The FDA's tentative approval under PEPFAR means that Matrix's product meets all of the agency's manufacturing quality, safety and efficacy standards.

Matrix's wide range of ARV products includes active pharmaceutical ingredients and 34 first- and second-line finished doses, eight of which are paediatric products. The company's emphasis on producing affordable products has allowed it to drive down the average annual cost per patient of effective therapies. Approximately 30% of HIV/AIDS patients in developing countries depend on a Matrix ARV product.

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

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NeoStem completes acquisition of Progenitor Cell Therapy

NeoStem, Inc. and Progenitor Cell Therapy LLC announced the closing of their previously announced merger transaction.  NeoStem is an international biopharmaceutical company with a 51 per cent ownership interest in a profitable Chinese generic pharmaceutical manufacturing company and has stem cell operations in the US and China, while Progenitor Cell Therapy, LLC is a privately held cell therapy company with operations on the east and west coast of the US serving the cell therapy community with cGMP state-of-the art cell therapy manufacturing facilities, and processing and storage facilities for stem cells collected from the umbilical cord at birth.

PCT's revenue generating business will complement NeoStem's growing adult stem cell operations and PCT's management adds to NeoStem the over 100 years' collective experience of the PCT management team in the business and science of cell therapy and its development.  Since its inception in 1999, PCT has served over 100 clients from around the world and has experience with more than 20 different cell based therapeutics.  PCT has performed over 30,000 cell therapy procedures in its cell therapy manufacturing facilities, and processed and stored over 18,000 cell therapy products (including approximately 7,000 umbilical cord blood units, 10,000 blood and marrow derived stem cell units and 1,000 dendritic cell units) and arranged the logistics and transportation for over 14,000 cell therapy products for clinical use by over 5,000 patients.

Dr. Robin Smith, MD, MBA, CEO of NeoStem said, "The merger with PCT is a significant step toward NeoStem's goal of becoming a leader in the fast-growing Stem Cell Industry, generating revenues, and developing and licensing therapies to be used in the United States and abroad.  We have purchased revenues and expertise, and reduced NeoStem's prior expense line as PCT was a vendor to NeoStem.  We are developing a 'one-stop-shop' global network of cell therapy core competencies by adding cell therapy manufacturing and storage facilities as well as integrated regulatory compliant distribution capacity for the evolving cell therapy industry.  The addition of PCT will allow NeoStem to focus on growing the cord blood and adult stem cell banking, cellular manufacturing and therapeutic business, as well as expanding our businesses in Asia and other countries, while continuing to develop our intellectual property and acquire new technology."

Dr. Andrew Pecora, PCT's CEO, will continue his involvement with the combined companies by shifting his role from PCT's chief executive officer to chief medical officer, and has been invited and has agreed to join the NeoStem board of directors.  Dr. Pecora said, "Our merger with NeoStem will provide the rapidly developing cell therapy industry with a dynamic global development and manufacturing platform that can accelerate the pace of commercialization of future cell therapeutics."

LifeTech Capital, an investment banking firm focused on the life science industry, advised NeoStem by providing a valuation analysis of the transaction.  LifeTech Capital is a division of Aurora Capital LLC.

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US FDA approves humanized anti-human IL-6 receptor monoclonal antibody Actemra to treat RA

Chugai Pharmaceutical Co, Ltd and F Hoffmann-La Roche Ltd announced that the United States (US) Food and Drug Administration (FDA) approved Actemra, the humanized anti-human IL-6 (interleukin-6) receptor monoclonal antibody (tocilizumab, RoACTEMRA in the European Union) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumour necrosis factor (TNF) antagonist therapies. Actemra, the result of research collaboration between Chugai and Osaka University, is the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody approved to treat RA, and may be used alone or in combination with methotrexate or other disease modifying anti-rheumatic drugs (DMARDs).

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FDA Rejects Arena's Diet Pill lorcaserin

FDA Rejects Arena's Diet Pill lorcaserin

 In recent pharma news is the rejection of arena's promising weight reduction pill by FDA

Arena pharmaceutical, based out of California,is research based bio-pharmaceutical company, generally working on development of drugs that target the activity of GPCRs (G-protein coupled receptors) generally in field of CVS,CNS, Inflammatory, metabolic area

1 year ago company detected promising molecule lorcaserin hydrochloride (lorcaserin),in treatment of weight management, successfully passed out phase - III clinical trials.

Lorcaserin was intended to duplicate the weight-reducing effect of one member of the fen-phen diet pill combination but without the side effects has succeeded in a small clinical trial, according to the drug's developer Arena Pharmaceuticals.
Company said that in clinical trial,obese patient who where given the highest dose of the Lorcaserin lost an average of 2.9 pounds after 28 days, compared with 0.7 pounds for those getting a placebo.

In December 2009, it submitted a new drug application (NDA),Food and Drug Administration (FDA) of USA, for regulatory approval.

on Friday, 22 Oct 2010 Arena announced that Food and Drug Administration has declined to approve Lorcaserin.

In September an advisory committee to the F.D.A. had voted 9 to 5 for rejection for approval,so rejection announcement is not quite surprissing.

The biggest issue behind declination of approval is meant to be production of tumors by Lorcaserin in higher dose in rat.
FDA asked for separate copy of data on animals & data assurance that result produced during higher dose in animal is not relevant with human.

The company's spokesman however told that the company has still hope that they will come back with more assured & PROMISING data,but what time was not specified.

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