Dr. Reddy

Biotech's next big opportunity: Follow-ons?

Thu, 24 Apr 2008 06:59:56 -0400

Follow-on biologics are often cited as major long-term threat to the biotech industry, which so far has not had to face a future where generic therapies are allowed to slice and dice the market for approved therapies. But new analysis from the RPM Report notes that biotech companies--along with the Big Pharma companies--may be much better positioned than generic drug developers to capitalize on the market.

The rationale is that developing follow-on proteins will demand exactly the kind of expertise that the biotech industry has on staff. Teva, meanwhile, has been on a buying spree and may be the only big generic developer that can compete in this space. Of course, before anyone produces follow-ons in the U.S. market, lawmakers have to agree on new legislation. And some proposals are calling for lengthy periods of exclusivity for biologics.

- read the analysis in the RPM Report

Dr. Reddy's joins with 7TM on research pact

Mon, 10 Mar 2008 07:59:56 -0400

India's Dr. Reddy's Laboratories is teaming up with 7TM on a drug discovery deal for metabolic disorders. Both companies agreed to collaborate on selecting new drug candidates, jointly advancing them through Phase IIa, when they can decide whether to license them out to another developer or take them on ahead as far as commercialization. The financial terms are being kept private.

"7TM has established a track record as one of the leading drug discovery companies focusing on GPCRs, and we are excited at the prospects of combining 7TM's capabilities with Dr. Reddy's to discover and develop innovative products," said Rajinder Kumar, Dr. Reddy's president.

- here's the release
- read the report from the Business Standard

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Debate over follow-ons focus on market exclusivity

Mon, 03 Mar 2008 06:59:54 -0500

The Boston Globe weighs in with a lengthy look at the tussle over biogenerics--a.k.a. follow-ons and biosimilars. The smart money is betting that at some point in the not-too-distant future Congress will get around to giving the FDA authority to approve biogenerics on a case-by-case basis. But don't expect the biotech lobbyists to back off of this issue anytime soon. As a concession, BIO is seeking 14-year market exclusivity for biotech drugs to compensate developers for the time it takes to gain approvals for these complex therapies. And they may come close: Lawmakers including Massachusetts' Ted Kennedy are backing a 12-year period of exclusivity.

- read the article in the Boston Globe

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Budget has mandate for biogeneric approvals

Tue, 05 Feb 2008 06:59:57 -0500

Buried in the modest 5.7 percent budget hike for the FDA is a provision that the government will seek authority to begin approving generic versions of biologics. Despite heavy support for the measure, lawmakers failed to get a bill in 2007 that would mandate a regulatory pathway for follow-on biologics, or biogenerics. The 1984 generic drug law excludes most biotech products, a feature that has enhanced the sector for investors and aroused the fiercely protective nature of a host of industry lobbyists. This time around, though, biogeneric legislation could get the boost it needs if the White House actively pursues it.

- read the report in the Wall Street Journal

ALSO: Opponents of a patent reform bill that changes the way damages are assessed in patent reform cases got a boost from the Bush Administration. Report

PLUS: Any big fix at the FDA may have to wait for a new president. The White House's proposed budget includes a funding increase of just 5.7 percent for the agency, a hike that's significantly absorbed by inflation. Report

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Teva snaps up CoGenesys in $400M buyout

Tue, 22 Jan 2008 06:59:56 -0500

Teva has whetted at least part of its appetite for fresh acquisitions with the announcement this morning that it is buying CoGenesys for $400 million in cash. The Israeli generic drug company says the buyout will give it a better position to compete in the fledgling biogeneric field. CoGenesys has drug candidates in the pipeline for cardiovascular disease, multiple sclerosis, diabetes and autoimmune diseases. It uses technology that retains therapies in the body for a longer period of time, reducing dosage requirements.

"CoGenesys' acquisition reflects our commitment to capture the significant long-term prospects we believe the biogenerics market will offer," said Teva CEO Shlomo Yanai in a statement. CoGenesys was a 2007 Fierce 15 company.

- see this release
- read the AP report

ALSO: It took a much sweeter offer, but Roche has prevailed in its bid to buy Ventana Medical Systems. Report

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In new approach, R&D units are spun off

Thu, 25 Oct 2007 06:59:56 -0400

In the old model for drug discovery, R&D is needed to provide a regular crop of new drug prospects to replace the therapies coming off patent. But that's not so in the generics world. Some of India's top generics companies are spinning off their R&D operations into separate companies. Ranbaxy Laboratories and Dr. Reddy's say that these spinoffs make more sense.

- read the report from the Financial Times

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SPOTLIGHT: India focuses on biosimilars

Tue, 25 Sep 2007 06:59:53 -0400

India sees a big future for itself in biogenerics. Wockhardt, Dr Reddy's Lab, Biocon, Sun Pharma, Shanta Biotech, Panacea Biotech and Ranbaxy Lab are all initiating programs to develop biosimilars in anticipating of U.S. approval of a new regulatory pathway--at some point. Exactly what that point is, though, remains a mystery. Report

ALSO NOTED: Novartis licenses MedImmune vaccine IP; Rumor Mill: Dr. Reddy bids for Bradley; and much more...

Fri, 24 Aug 2007 06:59:50 -0400

> Rumor Mill: Generic drugmaker Dr. Reddy's Laboratories is said to have submitted a bid for U.S.-based Bradley Pharma. FiercePharma

> Novartis has licensed MedImmune's reverse genetics intellectual property. Novartis will use the IP to support development of vaccine strains for seasonal, pre-pandemic and pandemic influenza vaccines. Financial details of the deal were not disclosed. Release

> Precision Therapeutics, which makes tests to analyze tumor cells, is planning an $80.5 million IPO. Report

> Two Massachusetts General Hospital researchers describe a way of creating novel enzymes that, for the first time, do not require prior understanding of exactly how the enzymes work. FierceBioresearcher

> A group of neurologists have been studying the role a particular enzyme plays in creating memories, saying that blocking the enzyme could offer a new approach to treating post-traumatic stress disorders as well as chronic pain. FierceBioresearcher

And Finally... The FDA wants more detailed sunscreen labels. Report

Dr. Reddy's make risky biogenerics move

Maureen Martino — Fri, 29 Jun 2007 10:12:42 -0400

At the Motley Fool, Brian Orelli analyzes a recent decision by India-based generic drug developer Dr. Reddy's Laboratories to spend $20 million to produce eight new generic versions of biologics over the next eight years and double its biogeneric operation to 340 people in the next two years. The drugmaker hasn't specified which drugs it plans to copy.

The biotech industry has long held that while it's not opposed to generic competition, manufacturing generic biologics is extremely complex process, and that generic drugmakers should be required to conduct clinical trials to prove the bioequivalencey of their drugs.

Dr. Reddy's move is risky, considering the FDA has yet to roll out a faster, less expensive route to generic approval. But given the sometimes astronomical costs of biotech drugs, and the fact that a number of biologics will be coming off patent in the next few years, the FDA has been fielding increasing demands for a faster biologic approval process. There is no such process yet, but it certainly seems that in the near future, the FDA will put in place a system by which generic biologics can prove their equavelancy to branded drugs without having to conduct costly clinical trials.

The manufacturing facilities required to make these drugs take time to build, but by getting a head start now, Dr. Reddy's will be able to beat out other generic developers and hit the ground running if and when the FDA green-lights a faster approval process. As Orelli observes, "The company is taking a huge risk to get ahead of the pack, but I think it's well worth the rewards of being in front of its competitors."

- see the Motley Fool article for more

Related Articles:
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ALSO NOTED: Medarex therapy gains fast track; J&J suspends trial; and much more...

Wed, 06 Dec 2006 19:01:30 -0500

> The FDA has put Medarex's MDX-010 skin cancer therapy on the agency's fast track. Report

> Johnson & Johnson says that problems experienced by a vendor in distributing drugs for the clinical trials of golimumab for RA will force it to temporarily suspend enrollment in some Phase III studies. J&J says it will resolve the problem quickly. J&J is co-developing the drug with Schering-Plough. Report

> India's Dr. Reddy's is developing a combinational therapy for heart disease. Report

> Basilea Pharmaceutical is exercising its co-promotional option with Cilag on an investigational antibiotic. Report

> WuXi PharmaTech and Merck have agreed to extend and expand an agreement through which WuXi provides a variety of chemistry-related R&D services. Release

> Researcher touts new work on insulin-producing cells. Report

> Scientists find potential Achilles heel in flu virus. Report

> Stem cell transplant may be successful against Parkinson's. Report

And Finally… A string of deaths this year has led some researchers to wonder if marathons are too much of a good thing for runners. Article