Aug 12, 2010

In order to tap the Indian market that offers not only cheap labour but also quality workforce, more and more Japanese pharmaceuticals and biotech companies are coming to India with business in mind. The latest to venture into India is aRigen, a drug discovery and development biotech company based in Tokyo.

Till recently Japanese investment in India had been low compared to investment in India by other countries. However during the last five years, there has been a spur of interest in Indian market.

In Japan, clinical trials are very costly and is not affordable thus more and more companies are looking out for countries which provide quality work at affordable rates. Dr Gensuke Tokoro, president & CEO, aRigen said that India is a very exciting market with lots of business opportunities, Japan looks at India as a frontier in the future with its strength in technology. Indian market is very interesting with quality as its main attraction.

“As a biotech company focused on drug discovery, our fundamental aim is to contain surging costs of developing and launching drugs globally. Since India has the potential to provide high quality service at a cheap rate it provides a lucrative option for any company who are looking for safe investment,” Tokoro averred.

Tokoro informed that since clinical trials are costlier in Japan they outsource it from outside, almost 80 per cent of clinical trials and licensing deals are done from Korea and India. He said that Indian companies should tap the Japanese market since both the countries can leverage the best out of each other.

While India has got talented scientist and work force that assures quality, Japan has a strong hand in R&D. Recently, aRigen out licensed Sorpex its antiviral drug for herpes to an Indian company Centaur Pharmaceuticals. The company plans to do more business deals with Indian companies in future. At present the company is working on a ulcer drug which the they may in future outsource to India. In the last ten years Japan has had 13 licensing deals of which seven deals were done by aRigen alone.

The Japaneses pharma companies first showed it interest in India in 2005, with Eisai Pharmaceuticals as the first Japanese phama company to set up operations in India by opening its corporate and marketing office in Mumbai. The second in the line was Astellas Pharma who had set up a sales subsidiary by November 2008, Astellas Pharma India in Mumbai. Followed by Daiichi Sankyo acquiring controlling stakes in Ranbaxy Laboratories in June 2008, soon after Takeda, the largest pharmaceutical company in Japan was also in line to have its clam in Indian market.

August 2, 2010

Isis Pharmaceuticals Inc will soon release key data from pivotal trials of its experimental cholesterol drug that will be closely parsed for evidence of any safety risks, particularly liver toxicity.

The drug, mipomersen, is designed to lower "bad" LDL cholesterol in patients with severely high cholesterol.

Isis is expected to report any day now results from two trials: one in patients with high cholesterol who are at high risk of heart disease and another in patients with a condition known as severe hypercholesterolemia.

Trial results released in February showed six months of treatment with the Isis drug lowered LDL cholesterol by 28 percent in patients with heterozygous familial hypercholesterolemia (HeFH) -- caused by a defective gene inherited from one parent.

But some patients developed elevated liver enzymes, a possible sign of liver damage, raising concerns regulators might require more studies before considering using the drug in patients beyond those so sick they would otherwise be dependent on an expensive blood filtering system.

The February trial results sent Isis shares down as much as 20 percent. The full data set is expected to be presented at a medical meeting later this summer.

"The one thing that could really hurt this drug is liver toxicity," said Cowen & Co analyst Eric Schmidt. He also noted the dropout rate for mipomersen trial patients has been fairly high because of injection-site reactions.

PARTNERED WITH GENZYME

Isis, which has partnered with Genzyme Corp GENZ.O> to develop mipomersen, argues that changes in liver enzymes are common with any drug that lowers cholesterol, including commonly-used statins such as Lipitor.

"Even today no one can tell you why statins cause liver enzymes to go up," Isis Chief Executive Officer Stanley Crooke told Reuters in a recent interview. "It's a general phenomena associated with adjustment of lipids."

Crooke said he was "quite comfortable" with mipomersen's safety profile.

Cholesterol-lowering drugs such as statins work by helping to clear LDL from the bloodstream by improving the action of LDL receptors. Mipomersen is designed to reduce actual production of the fatty material that can build up in artery walls.

The Isis drug, which is given weekly by injection, is based on a technology known as antisense, which aims to interfere at the genetic level to prevent rogue proteins from being formed.

Isis is a pioneer in the field and has a wide-ranging pipeline of experimental antisense drugs. Analysts, on average, have forecast mipomersen sales of $354 million in 2014, according to Thomson Pharma.

"All drugs that come up to the FDA (U.S. Food and Drug Administration) are looked at very carefully for liver issues these days," said Isis consultant Dr. Willis Maddrey, a liver expert and professor at the University of Texas Southwestern Medical Center.

He acknowledged elevated liver enzymes have been observed in roughly 10 percent of trial patients treated with mipomersen, adding "the important point is I haven't seen a single case of liver disease or liver injury."

Genzyme, which is expected to get a takeover bid any day now from France's Sanofi-Aventis SA, is responsible for regulatory applications for mipomersen.

Isis said any Genzyme buyer would take on the partnership, but, if that company did not want mipomersen, Isis would retain any money received and could relicense the drug.

The plan is to file in the first half of next year for approval of mipomersen for use by patients with homozygous familial hypercholesterolemia (hoFH).

Patients with familial hypercholesterolemia are unable to properly metabolize LDL due to dysfunctional LDL receptors.

There are two forms of the disease: hoFH, in which a defective gene is inherited from both parents, and heFH, in which a defective gene is inherited from only one parent so some LDL receptor function is preserved.

HoFH is estimated to affect about one in a million people worldwide. HeFH is a more common form of the disorder, affecting about one in 500 people.

Isis said the regulatory filings may also include patients with severe hypercholesterolemia.

The aim is to first address the highest-risk patients, followed by potential expansion into patients who have persistently high LDL levels despite being treated with other lipid-lowering drugs. These groups would include heterozygous FH, severe hypercholesterolemia, and high-risk patients who remain far from their LDL goals.

Trubion Pharmaceuticals, Inc. announced Pfizer's decision to discontinue development of TRU-015 (PF-05212374), an investigational drug in phase 2 evaluation for the treatment of rheumatoid arthritis (RA) developed under the companies' CD20 collaboration. However, Pfizer has confirmed that it will continue to develop SBI-087 (PF-05230895), Trubion's next-generation, humanized, subcutaneous CD20 RA product candidate also in phase 2 clinical evaluation.

Pfizer's decision is based on preliminary results from the phase 2b (2203) randomized, parallel, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of two dosing regimens (a single dose of 800mg TRU-015 compared with an induction dose of 800mg TRU-015 followed by an additional dose of 800mg TRU-015 at week 12) in combination with methotrexate in patients with active rheumatoid arthritis.

Although the ACR (American College of Rheumatology) 20/50/70 results in the phase 2 (2203) study were consistent with previous studies and similar to other B-cell-depleting therapies, the results did not meet the internally predefined primary endpoint, a 20% difference in ACR50 response compared with placebo at week 24 (p value = 0.06 for the single-dose group ACR 50 compared with placebo and p= 0.12 for the induction-dose group ACR 50 compared with placebo). A previously conducted interim analysis of the trial data on approximately 50% of the total enrolled patient population revealed that the primary endpoint had been met at that point in time. No significant safety issues were reported, and they were not a factor in Pfizer's decision to discontinue development.

TRU-015 demonstrated biologic activity including peripheral B-cell depletion and a statistically significant decrease in C-reactive protein in both dose groups compared with placebo. Specifically, ACR 20 was 67.1% for the induction-dose group, 61.3% for the single-dose group and 43.2% for the placebo group. ACR 50 was 27.4% for the induction dose, 29.3% for the single dose and 16.2% for placebo. ACR 70 was 9.6% for the induction dose, 9.3% for the single dose and 2.7% for placebo. TRU-015 was generally well-tolerated, and serious adverse events and medically important infection rates in both dose groups were similar to placebo.

"Given the higher than usual placebo response, TRU-015 did not meet the internal hurdle for continued development," said Scott C. Stromatt, M.D., senior vice president and chief medical officer at Trubion. "It is evident that the drug has significant biological and clinical activity with no significant safety concerns, but market dynamics dictate that we pursue a differentiated and best-in-class product to bring into phase 3 development. At this time our next-generation CD20 SMIP product candidate, SBI-087, meets that criteria, and its Phase 2 development will continue."

"Although we are not moving forward with this compound, we are encouraged by our analysis to date of SBI-087," said Evan Loh, senior vice president of BioTherapeutics Research and Development at Pfizer. "The goal of our collaboration with Trubion continues to be the development of best-in-class CD20 therapies, and we look forward to the results of the ongoing SBI-087 phase 2 study."

Trubion is a biopharmaceutical company that is creating a pipeline of novel protein therapeutic product candidates to treat autoimmune and inflammatory diseases and cancer.

3SBio Inc, a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, and Ascentage Pharma Group Corporation, Ltd have formed a strategic alliance to research, develop and commercialize best-in-class targeted cancer therapeutics focusing on programmed cell death, or apoptosis.