Teva

Indevus inks licensing pact, lands FDA deal

John Carroll — Mon, 29 Sep 2008 11:50:35 -0400

Indevus Pharmaceuticals ended last week on the upbeat news that it had struck a licensing deal for one of its experimental therapies and worked out an advantageous arrangement with the FDA on another drug up for approval. The news sent the company's shares up 86 percent.

Teva signed on to develop the stuttering drug pagoclone in a deal which is worth up to $92.5 million for Indevus in milestone payments. Under certain circumstances the deal can be structured for a 50/50 royalty split.

On another front, Indevus announced that the FDA gave it a green light to submit additional data for the testosterone replacement therapy Nebido rather than mount a new trial for the therapy. The agency's concerns are centered on adverse reactions at the injection site. Indevus can now resubmit its applications in the first quarter of next year rather than face a lengthy delay for a new trial. An approval could come in the fourth quarter of 2009.

- check out the Indevus release regarding the licensing deal
- read the Indevus release regarding the FDA agreement

Azilect data points to Parkinson's efficacy

John Carroll — Tue, 26 Aug 2008 11:12:18 -0400

Teva Pharmaceutical is touting the results of a late-stage study of Azilect, a treatment for Parkinson's disease. Researchers say the therapy hit all of its goals in the ADAGIO trial. Patients taking a once-daily oral dose of the drug reported a slowing of disease progression early on in the trial with a reduction in symptoms at a later point in the trial. The drug is already approved for treating symptoms of the disease, but Teva is looking to add an approval for disease modification.

- read the AP report

Copaxone disappoints at higher dose

John Carroll — Mon, 07 Jul 2008 10:53:00 -0400

Shares of Israel's Teva Pharmaceuticals slid after the company announced that a late-stage trial of a higher dose of its MS drug Copaxone did not perform better than a standard dose. 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

Follow-on legislation follows a twisted path in DC

Mon, 17 Mar 2008 07:59:57 -0400

BIO is toasting proposed new legislation that would provide more than 14 years of patent protection on a biologic. Needless to say, the generics crowd is just a tad disappointed by the bill, saying that patients would have to wait decades before they could benefit from any lower prices. "For the countless patients who are choosing between paying for their medicines and putting food on their tables, waiting decades is simply not an option," said the Generic Pharmaceutical Association. BIO feels a lengthy period of patent protection is the only fair option, given the time it takes to move a biologic to regulatory approval.

As the Wall Street Journal's blogsters point out, new legislation providing a regulatory pathway for biologics gets a thumb's up from most everyone--but no one agrees just how lawmakers should do it. One other commonly agreed point: Starting out, the FDA is likely to take it one biologic at a time, deciding when and how for each program.

- read the Generic Pharmaceutical Association statement
- read the report from the Wall Street Journal

Related Articles:
Waiting game continues for biogenerics. Report
Insulin debate spurs push for generic biologics. Report
Teva plans aggressive move into biogenerics. Report
Budget has mandate for biogeneric approvals. Report

DEALS: Teva buys CoGenesys for $400M

Thu, 31 Jan 2008 06:59:52 -0500

Teva buys CoGenesys for $400M

DEALS
WHO	WITH	WHAT	SCOOP
Pfizer	Washington University	$25M	Washington University and Pfizer researchers will identify, design and execute projects focused on immuno-inflammatory disorders such as arthritis, asthma and diabetes.
Forest Laboratories	Novexel's	$109.6 million	Forest gains development rights to Novexel's intravenous beta lactamase inhibitor, NXL 104, in combination with Forest's ceftaroline.
Teva	CoGenesys	$400 million	Teva says the buyout will give it a better position to compete in the fledgling biogeneric field.

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

ALSO NOTED: Sucampo Pharma names new CEO; Genetic tests are going DTC at a fast pace; Panel: Give FDA power to recall; and much

Tue, 06 Nov 2007 06:59:50 -0500

> Teva and the Technion Israel Institute of Technology are exploring a pact to develop stem cell lines for research work. Report

> Chutes & Ladders: Sucampo Pharma has named Kunihiko Soneoka as representative director, president and CEO. Release

> Predictive gene-based tests are going DTC, and a number of experts worry that it's all happening way too fast. Article

> A presidential panel is set to recommend giving the agency the authority to recall products all by its lonesome. Report

> The northward migration of drug buyers is slackening, according to pharmaceuticals datameister IMS Health. In 2006 U.S. customers only spent $211 on meds from Canadian pharmacies, compared with $420 million in 2005. Report

> Better late than never, Bristol-Myers Squibb might say. In a move that's sure to incite debate, the FDA says it will allow BMS to market its schizophrenia med Abilify for use in adolescents. Report

> Can poor countries get the meds they need for their people only by circumventing patents? That's the debate this week at a WHO confab aimed at supplying the developing world with the drugs it needs. Report

> A report in the Journal of Clinical Investigation sheds new light on the role of WNK kinases in regulating blood pressure, which in likely to trigger research into new therapies for the very common, lethal disease. Report

> What do Tokyo teenagers falling from buildings have in common with Roche? Possibly Tamiflu. Report

And Finally… A novel vaccine developed at The Scripps Research Institute at La Jolla may offer a new way to block infections without sparking bacterial resistance. Report

Teva's lupus drug flunks Phase II

Wed, 19 Sep 2007 06:59:56 -0400

Teva says its Phase II trial for the experimental lupus drug edratide failed to hit its primary endpoint. The weekly therapy failed to cut the rate of disease activity after 26 weeks of treatments. Teva says it will make a final determination on how to proceed after it crunches the numbers for secondary endpoints. The drug appeared safe and was well tolerated.

- check out the release for more info

Related Articles:
Teva plots strategy on high-risk rollout. Report
Roche, Teva square off in patent fight. Report

ALSO NOTED: Flamel inks licensing deal;Alfacell trial hits a milestone; and much more...

Wed, 12 Sep 2007 06:59:50 -0400

> France's Flamel Technologies gets an undisclosed upfront payment and a schedule of potential milestone payments after signing a licensing and development deal with Wyeth for using its technology to deliver a marketed protein. Release

> Alfacell Corporation has confirmed that 290 evaluable events--patient deaths--have occurred in the Phase IIIb clinical trial of its lead compound, ONCONASE, for unresectable malignant mesothelioma. Release

> Prana Biotechnology has raised $7 million in a private placement. Release

> What's a generic drug company to do? A federal judge refused Wyeth's request for an injunction against the launch generic Protonix, and Teva could start selling. But if Wyeth wins the patent case, then Teva would have to fork over three times its sales. Report

> An outbreak of foot-and-mouth disease in the UK has been contained after a government report pinned the blame for the outbreak on leaky pipes at the Institute for Animal Health's Pirbright site. Report

> The NIH has doled out $438 million for daring research projects. Report

> And Finally... Venture capitalists bet big on nanotechnology. Report

ALSO NOTED: Teva invests in stem cell start-up; Anacor files for IPO; Merrion sets terms; and much more...

Tue, 04 Sep 2007 06:59:50 -0400

> Teva is investing $1 million in the stem cell start-up Cell Cure Neurosciences. Report

> Anacor Pharmaceuticals has filed documents for an IPO designed to raise $57.5 million. Report

> Ireland's Merrion Pharmaceuticals says it plans to offer four million shares in its IPO at $10 to $12 per share. Report

> Celera is buying Berkeley HeartLab for $195 million in cash. "Celera's genetic markers that are intended to identify people at risk for early heart attacks, stroke and blood clots and optimize therapy with cholesterol-lowering drugs, aspirin, anti-coagulants and other cardiovascular drugs should augment Berkeley HeartLab's current disease management offerings to patients," said Kathy Ordonez, president of Celera. Report

> The FDA has approved a new vaccine--ACAM2000--for use against smallpox. Release

> Jerini announced the termination of the license agreement between its affiliate, Jerini US, and Kos Life Sciences, Inc. for the development, marketing, and distribution of Icatibant in the United States and Canada. Release

> More proof that India is the new headwaters of generic drug-making: Watson Pharmaceuticals got the FDA to sign off on its production facility in Goa, India. Report

And Finally… Craig Ventner's new work sequencing his own diploid genome has created a new "gold standard" in the field of genetics. FierceBioResearcher

ALSO NOTED: FDA OKs human thrombin; A new cancer research company; Compugen inks drug pact; and much more...

Tue, 28 Aug 2007 06:59:50 -0400

> Shares of Omrix surged this morning on the news that the FDA had approved Evithrom, a protein used to control bleeding during surgery. This is the first human thrombin to gain approval since the '50s. Report

> Cancer Therapeutics CRC has begun operations by billing itself as one of the largest public/private partnerships of its type in the world. Working with AUD$148 million in funding over seven years, including AUD$37.6 million from the Australian Commonwealth Government, "CTx addresses the gap between Australia's excellent academic cancer research base and its ability to discovery and develop new drugs to treat cancer." Release

> Israel's Compugen says it has inked a research collaboration and commercialization option with Teva for its chronic inflammatory disease treatment candidate CGEN-54. Release

> Neuro-Hitech has named Dr. Gary Shearman president and CEO. Release

> CuraGen and TopoTarget have initiated patient dosing in a Phase I/II clinical trial evaluating belinostat (PXD101) in combination with the anthracycline idarubicin for the treatment of Acute Myeloid Leukemia. Release

> Biogen Idec says another month has gone by with no new reported cases of PML among Tysabri patients. PML is a rare brain disease that has been linked to the MS therapy. FiercePharma

> The FDA has accepted the marketing application from Merck and Schering-Plough for a drug combining allergy and asthma blockbusters Claritin and Singulair. FiercePharma

And Finally... A longevity gene may be the key to living past 100. Report

Lundbeck chair exits as company seeks calm

Mon, 27 Aug 2007 06:59:54 -0400

Denmark's troubled H. Lundbeck, which has been roiled by the failure of two late-stage trials and a delayed rollout of a U.S. sales force, is bidding goodbye to its chairman. Flemming Lindeløv's departure comes as a gesture to "restore calm," says the company. But with two big patents expiring in 2012 and 2014, analysts are looking for more success on the development side. Lundbeck has been under considerable pressure to acquire new therapies or find a bigger pharma company to merge with.

- see this release for more

Related Articles:
Merck, Lundbeck end gaboxadol development. Report
Teva, H. Lundbeck stop work on oral Copaxone. Report
Lundbeck's shares plunge as drug flunks Phase III. Report

Momenta sees delay in generic Lovenox development

Thu, 28 Jun 2007 00:01:38 -0400

Shares of Momenta took a hit after the company warned that its development of a generic version of Sanofi's blood thinner Lovenox is likely to take longer than expected. Shares slid 15 percent on the news that the regulatory review of its abbreviated new drug application would take longer than the 18 to 24 months originally expected. Momenta is developing M-Enoxaparin with Sandoz, the generic arm of Novartis. Momenta is considered one of the key players in the development of a new generation of follow-on biologics. Sanofi has argued that its blockbuster Lovenox is too complex to be copied. But a judge opened the door to a competing therapy last February with a ruling invalidating the patent on the injectable. Momenta is competing with Amphastar Pharmaceuticals and Teva to do just that.

- read the AP report on Momenta's worries

Analysis: A bipartisan group of Senators is forming to back a new bill that would grant four years of exclusive sales to a biologic before it faced generic competition. The bill also would allow follow-on drugs to be marketed as interchangeable and that generic developers would have to mount at least one clinical trial for approval--with a proviso that the FDA could waive that requirement. Report

Related Articles:
Sanofi loses Lovenox patent protection. Report
Lovenox reduces cardio risks but can cause bleeding. Report
Sandoz takes big stake in Momenta. Report

Merck KGaA confirms possible sale of generics unit

Thu, 04 Jan 2007 19:01:34 -0500

Germany's Merck KGaA has confirmed yesterday's rumor that it is considering the sale of its generics drug business. A sale would net billions of dollars for the drug company, which also announced that it had completed the acquisition of Switzerland's Serono and is focusing on new drug development. Israel's Teva, Sanofi-Aventis and Novartis have been named as potential suitors. The global generics business has seen a wave of buyouts over the past year as the industry consolidates around a short list of key players.

- see this release for more
- here's the AFX report on the confirmation
- here's the report from Globes on possible suitors
- more on suitors from this AFX report

ALSO: A Dutch newspaper claims that Akzo Nobel is in talks to sell its Organon drug subsidiary. Report

SPOTLIGHT: Report: Teva CEO to step down

Tue, 17 Oct 2006 20:01:33 -0400

The Israeli daily Yediot Achronot is reporting that Teva CEO Israel Makov is planning to step down. Teva, one of the world's largest and most aggressive generic drug makers, will reportedly be run by Shlomo Yanai, the chief executive of the agrichemicals producer Makhteshim Agan. Trading of Teva shares was halted on the news. Report

Rumor Mill: Mayne Pharma may be takeover target

Tue, 19 Sep 2006 20:01:37 -0400

Shares of Australia's Mayne Pharma are on the rise following hot rumors that it's about to become the subject of a takeover bid. Two generic drug outfits, Hospira and Teva, have been suggested as possible bidders. But other analysts are speculating that the rumors are being triggered by a possible bid by Mayne for another company. Spun out last year from the Mayne Group, Mayne Pharma has been posting losses while boasting of its new drug candidates.

- here's the report on Mayne from The Australian

PLUS: One report suggests that $1.5 billion is being offered for Mayne. Report

ALSO: Mayne Pharma CEO Thierry Soursac has earned $3.8 million since the spin-off. Report

ALSO NOTED: Procognia, Teva to collaborate; FDA questions Trasylol; and much more...

Tue, 19 Sep 2006 20:01:30 -0400

> In a new collaboration deal, the UK's Procognia will give Teva access to its proprietary glycoanalysis technology as the cooperate on the development of two drug candidates. Teva will fund the work and pay an unspecified set of milestones. Report

> FDA staffers are questioning the deaths and allergic reactions seen in the testing of Bayer's heart surgery drug Trasylol. Report

> The backers of embryonic stem cell research in Michigan have launched a new organization that they hope will eventually overturn a state ban on buying embryonic stem cells from in vitro fertilization clinics. Report

> A scientific consortium led by the University of North Carolina in Chapel Hill will receive a $21.3 million grant to research new drugs for African sleeping sickness (Trypanosomiasis) and Leishmania. Release

> Active Biotech is touting positive results from a Phase I study of a prostate cancer therapy. A Phase II/III study is scheduled for next year. Report

> The FDA has accepted Vernalis' NDA for Frova, a therapy for preventing menstrual migraine. Report

And Finally… A new study shows that Vitamin D can reduce the risk of pancreatic cancer. Article

Actavis ups ante in bidding war for Pliva

Wed, 30 Aug 2006 20:01:37 -0400

Iceland's Actavis has upped its bid to acquire Croatia's Pliva to $139 a share, surpassing the latest offer from Barr. But analysts say the bidding war isn't over yet. They're waiting to see how Barr reacts to this latest bid and many expect yet another higher bid to hit the table. The winner in the bidding war for Pliva will create the world's third largest generic drug maker, behind Teva and Novartis.

- see the AFX report on Actavis' bid

Generic drug makers line up for biogenerics

Tue, 15 Aug 2006 20:01:36 -0400

Speculating about the potential impact of biosimilars--or biogenerics--is all the rage these days. Teva and Barr Laboratories appear to be best positioned to take advantage of new biogenerics but the industry has been fiercely resisting any acceptance of them, claiming their therapies are too complex to permit knockoffs from competing with them. The generic makers, meanwhile, say that the real resistance has more to do with a reluctance to let another company drag down prices. And everyone is waiting on the FDA to do something as the pressure for change continues to grow and grow.

- here's CNNMoney.com's take on the subject