Generics

Report: Pfizer makes counter-offer for Ranbaxy

Maureen Martino — Fri, 13 Jun 2008 10:06:09 -0400

Pfizer may be crashing Daiichi Sankyo's party. Business Standard is reporting that Pfizer is considering a counter-offer for Ranbaxy, India's largest drugmaker. The rumor comes on the heels of the $4.6 billion offer Daiichi made just two days ago. Sources say Pfizer may "make a bid for 41.3 percent of the company from institutions and another 21.2 percent from individual shareholders." None of the companies involved have confirmed the rumors.

So why would Pfizer be interested in Ranbaxy? It turns out that there are plenty of reasons. An acquisition of Ranbaxy would give the world's largest drugmaker a big slice of the hot generic drug market. The other big reason? Lipitor. Ranbaxy is planning to launch a generic version of the $10.1 billion-a-year earner in 2010, and wouldn't it be nice for Pfizer if it could control that bit of competition? There's no word on what Ranbaxy's thoughts are on the deal. Ranbaxy says the deal is already done and that it's too late for Pfizer to make a bid, but this battle may just be getting started.

- read the WSJ report
- here's a Forbes article for more

Daiichi Sankyo acquires Ranbaxy in $4.6B deal

John Carroll — Wed, 11 Jun 2008 11:12:29 -0400

Ranbaxy's drive to become a research-based drug developer and major manufacturer has led it straight into the welcoming arms of Japan's Daiichi Sankyo, which announced it is buying a majority stake in the Indian pharma company. After Sankyo completes a buyout of the founding Singh family's stake in the company, Ranbaxy will become a subsidiary operation. The deal is valued at $4.6 billion and will create a combined company worth about $30 billion.

That move positions Daiichi Sankyo to become a major supplier of low-priced generics to Japan's aging population and accelerates a trend by Japanese pharma companies to enter emerging Asian markets, where they see much of their future growth. The acquisition stunned investors and analysts alike, who were caught off guard by a bold move from a conservative player in the industry.

- check out this release for more on the deal
- read the report from The Times

ALSO NOTED: GSK releases new Cervarix data; FDA mulls DTC ads; and much more...

Fri, 16 May 2008 06:59:50 -0400

> GlaxoSmithKline has released new Cervarix data that demonstrates the vaccine's ability to generate a high and sustained level of antibodies to neutralize the two most prevalent strains of cervical cancer for up to 6.4 years. Cervarix report

> The French pharma industry worries that up to 32,000 jobs are fodder for the axe, citing pricing pressures, generics, and globalization among the threats to drugmakers. Report

> Brace yourselves: An FDA advisory committee meets today to hash over the possibility of putting a side-effects hotline number in every DTC television commercial. Release

And Finally... The five key vaccine makers say they plan to produce a record 143 million doses of flu vaccine for the U.S. market next season, which should be enough to satisfy demand. Vaccine report

Pfizer gets new cancer team to advance key drugs

Thu, 15 May 2008 06:59:56 -0400

With the clock ticking on its patent for Lipitor, Pfizer has turned to a group of new executives to lead the company to the promised land of new cancer therapies.

Garry Nicholson, a 30-year Eli Lilly vet, will be responsible for overseeing every aspect of Pfizer's new oncology programs, from the first clinical trial to marketing, notes Forbes. Neil Gibson, formerly chief scientific officer at biotech OSI Pharmaceuticals, has been brought in to direct oncology research. And Briggs Morrison, who was able to speed clinical trials at Merck, has been brought in to do trial design.

"It's an exceptional situation," says Nicholson. "And for someone like me, who is in the business to get as many cancer drugs that extend survival to patients as possible, it is the best situation that I know of."

Pfizer needs all the help it can get. The drug giant is likely to lose 25 percent of its current revenue to generic competition for Lipitor.

- see Pfizer's statement on Nicholson's appointment
- read the article from Forbes

Spectrum sells off generic drugs

Fri, 09 May 2008 06:59:55 -0400

Specturm Pharmaceuticals has sold its abbreviated NDAs for its injectable generic drugs, ondansetron, carboplatin, fludarabine, and mitoxantrone, to Sagent Pharmaceuticals. Sagent, which made our list of the top 20 VC deals of 2007, brings finished pharmaceutical therapies onto the U.S. market and is focused on injectable products. "The sale of these non-core assets provides additional non-dilutive funding which will be used to further fund the advancement of our late stage clinical programs," said Rajesh C. Shrotriya, Spectrum's CEO. Spectrum has 12 drug candidates in the clinic and three more in preclinical development.

- check out Spectrum's release

ALSO NOTED: Analysts predict trouble for second-gen Rituxan; Sucampo earns $50M on FDA approval;and much more...

Wed, 30 Apr 2008 06:59:50 -0400

> Jim Reddoch, a biotech analyst with Friedman, Billings & Ramsey, is raising some interesting questions about Genentech's second-generation anti-CD20 antibody that is in development as a more benign version of Rituxan. Given the recent trial failure in lupus, Reddoch tells Pharmalot that he's more skeptical about its chances when the more potent Rituxan fails to hit endpoints in a trial. And that could eliminate a potential "growth area" for the biotech giant. Report

> Sucampo has won a $50 million milestone payment on the FDA's approval of a new indication for Amitiza. Report

> A JDRF collaboration between Johns Hopkins researchers and Genentech has shown that a drug for the treatment of diabetic eye disease--ranibizumab--has performed better in clinical trials than the current standard treatment using laser surgery. Release

> Metabasis Therapeutics announced Monday that its experimental therapy for type 2 diabetes hit its endpoints in a Phase IIa trial. Release

> What's bad for Merck is good for Abbott Labs. When the FDA said "no" to Merck's niacin-based cholesterol treatment Cordaptive, it raised the prospects for Abbott's extended-release form of niacin, Niaspan, and its regular niacin drug Simcor. Abbott report

> The FDA finally put its mouth where the money is. During congressional hearings yesterday, CDER chief Janet Woodcock said the agency would need $225 million to $250 million in additional funding to inspect foreign plants as frequently as it does in the U.S. FDA report

> Consider this scenario from Fred Hassan's nightmares: The $800 million Clarinex, ostensibly under patent till 2020, falls early victim to generic competition. Clarinex report

> Last fall AstraZeneca EVP David Smith said the company was looking to outsource most of it manufacturing, but then backpedaled after the ensuing outcry. Now the company has affirmed a big chunk of those outsourcing plans. Outsourcing report

> Management consultant Dr. David A. Shaywitz has joined with Dr. Dennis A. Ausiello, the physician-in-chief of Massachusetts General Hospital and a director at Pfizer, to deliver a rebuttal to a small group of research scientists who have sworn off any industry-financed drug research work. Report

> Pfizer is providing $14.4 million to fund a research consortium involving four universities and Entelos, a company that does computer modeling for drug research work, in a drive to create a new class of diabetes drugs. Report

And Finally...
Two new human trials of a gene therapy for inherited blindness have demonstrated that injecting replacement genes under the retinas of the blind can spur at least partial sight in some volunteers. Report

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

ALSO NOTED: US Oncology's CFO retires; Profits rise at Novartis, Merck, Lilly; and much more...

Mon, 21 Apr 2008 06:59:50 -0400

> US Oncology's CFO Rick McCook is resigning to explore opportunities in a retail or manufacturing business. Release

> Good financial results from three Pharma biggies should cheer up those market-watchers who moaned their way through much of last week. Sure, a couple of the profit leaps came at least in part from one-time gains. But increases are always better than the alternative. Report

> Seeking Alpha profiles Synta's metastatic melanoma therapy Elesclomol. Report

> Last week, we reported on Big Pharma's march on the capital in support of new off-label marketing rules. Now, opponents of those rules are drawing on another of last week's news events for support: the Vioxx ghostwriting story. Report

> A Roche distributor tattled to India's Drug Controller General, accusing Cipla of promoting its generic version of a Roche drug for an unapproved use. Report

And Finally... Higher food prices and grain shortages are changing attitudes toward biotech crops. Report

ALSO NOTED: Meda buys late-stage drugs;Debiopharm licenses peptide;and much more...

Mon, 14 Apr 2008 06:59:50 -0400

> How might drugmakers navigate the rocky waters of generic competition, cautious regulators, safety scandals, globalization, and so on? Seek help with the itinerary from an expert, perhaps. At least six top U.S. drugmakers have done this, putting strategy gurus in top offices. Report

> Meda has paid $20 million for the exclusive world-wide commercialization rights from Orexo of two patented drugs in late development phase; Sublinox and OX-NLA. Release

> Analytical NanoTechnologies has inked an agreement to acquire the entire issued share capital of Microarray for £1 million. Report

> Debiopharm Group has inked an option and license agreement with Airmid to develop an ShK peptide called Debio 0824, a potassium channel blocker currently in early preclinical development for autoimmune diseases. Release

> Introgen Therapeutics says that ADVEXIN Phase III clinical trial data in patients with recurrent head and neck cancer confirm earlier Phase II results of ADVEXIN efficacy. Release

> Alfacell announced that Dr. Intae Lee with the University of Pennsylvania has reported that Alfacell's Onconase (ranpirnase) could be a promising radiation sensitizer for lung cancer treatment. Release

> Nuvelo announced preclinical data demonstrating the mechanism of action and the potent therapeutic activity of NU206 (R-spondin1) in chemotherapy or radiation-induced oral mucositis models. Release

> Misleading minutes, swearing execs--just another day at the office for Vytorin's critics. Report

> If you had any doubt why Pfizer, GlaxoSmithKline, and other Big Pharma companies are drooling over business in the developing world, take a look at a new Deutsche Bank report on the Indian drug market. Report

And Finally… Co-pays on some expensive biotech drugs can now climb as high as 33 percent. Article

Can Big Pharma effectively develop new drugs?

Fri, 04 Apr 2008 07:59:57 -0400

When it comes to drug development, is bigger really better? That is the question Borje Eckholm, president and CEO of Investor AB--and one of AstraZeneca's biggest shareholders--poses in the London Times. Big Pharma is under increasing pressure to churn out blockbuster drugs while at the same time control costs, fend off generic competition and create shareholder value. Eckholm thinks the vertically integrated pharma model can't effectively meet all those demands.

"You have to ask yourself: Do you have economies of scale in R&D? It's not clear but one of the fundamental ways that companies create value for shareholders is strong R&D. It raises the question: is big better? Maybe you have to split it up into smaller parts." He suggest that Big Pharma would be better off outsourcing projects to smaller developers who posses the independent spirit needed to discover groundbreaking new drugs.

Some of the industry's biggest players have indicated that reorganization is necessary. Pfizer, for instance, has set up a biotech incubator to foster growth. Meanwhile, AstraZeneca has established a biotech focus, merging purchases Cambridge Antibody Technology (CAT) and MedImmune into one biologics powerhouse. The company also spun off its Swedish R&D facility for gastrointestinal therapies.

- read more in this London Times report

ALSO: Can pharma police its own globalization? Report

Related Articles:
Is pharma addicted to blockbusters? Report
Spin-off may signal new era for Big Pharma R&D. Report
AstraZeneca may shake up R&D with spin-off. Report

Novartis discovery chief departs in management shakeup

Thu, 20 Mar 2008 07:59:56 -0400

Restructuring under the gun of new generics and after being slammed by regulatory defeats, Novartis is bidding adieu to James Shannon, its chief of global drug development. In his place Novartis has appointed Trevor Mundel and Andrin Oswald. Shannon's departure comes soon after Alex Gorsky decamped from his post as head of North American pharmaceuticals to take a job at J&J. Novartis provided little cover for Shannon's departure. A spokesperson said she had no idea what Shannon was planning to do next. Novartis has been reorganizing since the constipation drug Zelnorm was withdrawn and its diabetes pill Galvus was delayed.

- read the report in the Wall Street Journal

Related Articles:
Novartis' Gorsky to return to J&J. Report
U.S. CEO exits Novartis. Report
CEO: Novartis plans big restructuring. Report
Lagging sales spur Novartis layoffs. Report

Pfizer seeks salvation in late-stage biotherapeutics

Wed, 05 Mar 2008 06:59:58 -0500

Pfizer's Jeff Kindler (photo) has boldly staked out plans to make 15 to 20 regulatory filings for new drug approvals and expanded use of existing drugs between 2010 and 2012, insisting that the pharma giant can gin new revenue to replace the $12 billion a year it will see evaporate when Lipitor loses its patent protection. In a highly anticipated meeting with analysts this morning, Kindler outlined how Pfizer is bracing itself for the massive losses connected with generic competition for Lipitor--a fateful moment that could come as early as 2010. Expanding aggressively into China and Latin America will help, he told the analysts, who were more eager to hear how Pfizer intends to compete in the U.S. market, which provides the bulk of its drug revenue. And Pfizer insists it will continue to lower costs as it finds the "right size" relative to income.

Pfizer has been on a buying spree lately, snatching up biotech programs and companies in its bid to stay competitive and boost income. In the meeting this morning executives said that between 15 and 20 mid-stage therapies would shift into late-stage trials by the end of next year. During that time, Phase III trials will jump by 50 percent to 75 percent, to 24 to 28 programs. They currently have 16 Phase III trials underway. In the process, says Pfizer, the company intends to become a top-tier biotherapeutics player.

- read Pfizer's release
- check out the AP report
- read the Dow Jones story

ALSO: As Pfizer held its big conference call this morning, the New York Daily News was reporting on the company's job cuts and plant closure in Manhattan and Brooklyn. At issue: a $10 million tax-break package the drug maker got in return for creating new jobs in New York. Pfizer was supposed to be on the hook for boosting employment to 8,659 from 5,735. Report

Related Articles:
Is Pfizer's CEO as bold as promised? Report
A look inside Pfizer's biotech center. Report
Pfizer hires new R&D chief, launches biotech center. Report
Speculation soars over Pfizer's interest in biotech. Report
Pfizer's future rests with biotech. Report

ALSO NOTED: Harvard launches fund for biomedical tech; Neurogen outlines R&D plans; and much more...

Fri, 08 Feb 2008 06:59:50 -0500

> Harvard University's Office of Technology Development has launched the second round of its Technology Development Accelerator Fund, a new initiative designed to propel emerging technologies originating from the university's biomedical and life science research community into the marketplace. Release

> Following the decision earlier this week to cut 70 employees, Neurogen has updated the status of its later stage clinical portfolio and announced the future focus of its research efforts. Neurogen intends to pursue five unpartnered clinical programs in 2008 to address anxiety, insomnia, Restless Legs Syndrome (RLS), Parkinson's disease and schizophrenia. Release

> GTC Biotherapeutics has agreed to sell some of its stock in order to raise about $6 million. Report

> A Phase III clinical trial of Labopharm's once-daily formulation of the antidepressant trazodone achieved statistical significance for the primary efficacy endpoint. The company is preparing to submit an NDA for the drug. Release

> The Maryland Department of Business and Economic Development has invested $50,000 in Sirnaomics, a Gaithersburg drug development company. Report

> You can't say Merck does things in a small way. The company has agreed to pay $671 million to settle claims that it overcharged the government for drugs and bribed doctors to prescribe certain meds. Report

> Incoming GlaxoSmithKline CEO Andrew Witty has a tough job. He's inheriting the company at a time when Avandia safety questions are dragging down sales and when generic competition is circling five drugs. Yesterday, the company predicted a decline in earnings for his inaugural year, and GSK shares tumbled. The answer? Witty says diversify. Report

And Finally... A new study in macaques suggests that antiretroviral drugs used to treat HIV could also protect people from getting the AIDS virus. Report

The 2008 Election: What does it mean for drugmakers?

Maureen Martino — Wed, 06 Feb 2008 09:02:01 -0500

The winner of the 2008 election will be faced with making key decisions on a number of issues important to drug developers. Questions as to whether there will be more federal funding for stem cell research, a faster path for biogenerics, or a change to the structure of the nation’s healthcare system will have to be addressed by the next president, and how they tackle those issues will have serious repercussions for the industry. Here’s a look at the front-runners’ stance on several topics vital to the biotech and pharmaceutical industries.

Barack Obama supports:

Reimportation of drugs
Greater generic drug use by Medicare, Medicade, ect
Establishing a government institute for comparative research between drugs.
Allowing the government to purchase prescription drugs in bulk to reduce costs.
Universal healthcare
Embryonic stem cell (ESC) research

Hilary Clintion supports:

Doubling NCI and NHC funding
Increaseing the number of patients involved in cancer clinical trials.
A pathway for biogenerics
Lower prescription drug costs and universal health care
Giving Medicare the power to negotiate prescription drug prices
Stricter control of drug advertising
ESC research

John McCain supports:

A pathway to approve biogenerics
An increase use of generic drugs
Reimportation of drugs
Allowing the government to negotiate lower prices for prescription drugs for the Medicare Part D program
ESC research

- see this Motley Fool article for more

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

Related Articles:
Waiting game continues for biogenerics. Report
Dr. Reddy's make risky biogenerics move. Report
Lawmakers propose pathway for approving biosimilars. Report

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

Related Articles:
Teva earmarks $1B for India. Report
Waiting game continues for biogenerics. Report
Dr. Reddy's make risky biogenerics move. Report

Novartis CEO: Galvus' future is uncertain

Thu, 17 Jan 2008 06:59:58 -0500

Long delayed by a wary FDA, Novartis CEO Daniel Vasella (photo) now says that the diabetes drug Galvus may never be refiled for approval in the U.S. Safety issues arising around liver enzyme levels have twice prompted regulators to pass on approving the DPP-4 inhibitor--allowing Merck to beat it to the market with Januvia. Novartis and the FDA have been engaged in talks about what kind of data is needed to get an approval, but Vasella made it clear in a chat with analysts that no new trial will be mounted until the company gets a clear understanding of what the regulators are looking for.

"It's on the cards that we won't refile, but it's also on the cards that we will," he said in a report carried by Dow Jones. "But what is certainly clear, is that refiling without new data makes no sense." Vasella was also left to explain why Novartis fell far short of Wall Street's expectations for the fourth quarter as generic competition cut deep into its net profits.

- read the report in the Wall Street Journal Health Blog

Related Articles:
Novartis faces delay rolling out Galvus. Report
Galvus delay raises questions about drug class. Report
FDA expected to approve Januvia soon. Report
FDA demands new trial for Galvus. Report

European pipeline likely to stay thin to 2009

Mon, 14 Jan 2008 06:59:57 -0500

GlaxoSmithKline appears to be best situated among the European pharma companies to weather the drought of new products that set in with a vengeance in 2007 and appears to be continuing well into 2008. Glaxo launched nine late-stage studies last year, an encouraging sign to the analysts. Roche also has been active on the research front, though mostly in the pursuit of new approvals for existing meds.

But overall, say the analysts, don't look to Europe for many new chemical entity approvals in '08. Many are looking past this year into 2009, when Big Pharma faces a slate of patent losses for blockbusters. Sanofi, which faces looming generic competition, is betting on experimentals like aflibercept and S-1 and the antidepressant saredutant to save the day. Without new products to take their place, many of these giants are likely to feel a significant amount of heat.

- check out the report from BusinessWeek

Related Articles:
UK biotechs feeling the chill from investors. Report
Europe moves to reclaim center stage. Report
Group: EU should double research spending. Report
The trouble with Europe. Editorial

Idera shares surge on Merck KGaA pact

Wed, 19 Dec 2007 06:59:58 -0500

Idera is pocketing a $40 million up front fee from Merck KGaA and hopes to make an additional $381 million in milestones from licensing its technology for cancer therapies. The German Merck gains exclusive rights to Idera's two most advanced Toll-like Receptor 9 (TLR9) agonists for cancer--IMO-2055 and IMO-2125--for all uses with the exception of cancer vaccines. These Toll-like receptors are sentinels for chemicals in pathogens for cancer, infectious diseases, respiratory and autoimmune disorders. IMO-2055 has been involved in Phase I studies for solid tumors that have been unresponsive to standard therapy. Shares of Idera surged on the news.

- see the release
- here's the AP's report on the deal

Related Articles:
Idera inks $455M pact for Merck vaccines. Report
Merck KGaA CEO eyes new acquisitions. Report
Mylan inks $6.6B deal for Merck's generic drug biz. Report
Merck KGaA buying control of Serono. Report

SPOTLIGHT: India emerging as big drug market

Tue, 18 Dec 2007 06:59:53 -0500

Indian pharma companies have had to weather a series of big changes in recent times, including big pharma's successful strategy in aggressively challenging generics. But the Wall Street Journal's trend piece also notes that over the next decade Indians' appetite for drugs will grow from $8 billion to $30 billion, making it an important market for the drug companies. Report