GlaxoSmithKline

Promacta gets FDA approval

Maureen Martino — Fri, 21 Nov 2008 08:46:20 -0500

The FDA has approved GlaxoSmithKline and Ligand Pharmaceuticals' Promacta (eltrombopag). The drug treats a rare immune condition called thrombocytopenia purpura, in which a patient's immune system attacks its own platelets. Promacta is the first oral thrombopoietin receptor agonist therapy for the treatment of adult patients with chronic ITP. Release

GSK to withdraw, resubmit RLS app.

Maureen Martino — Mon, 10 Nov 2008 10:58:30 -0500

GlaxoSmithKline and XenoPort have withdrawn their NDA for Solzira, a treatment for moderate-to-severe primary Restless Legs Syndrome. The FDA wants data in a single study to be reformatted, and GSK will conduct a review of other trial data sets taking this input into account. The companies stressed that the withdraw isn't in relation to the content of the filing, and that Solzira would be re-filed as soon as the adjustments are made. The withdraw delays GSK and Astellas Pharma's $23 million milestone payment to XenoPort.

- see the release for more

GSK buys Genelabs for $57M

Maureen Martino — Thu, 30 Oct 2008 10:22:43 -0400

In a move designed to bolster it's hepatitis C offerings, GlaxoSmithKline is buying Redwood City, CA-based Genelabs Technologies for $57 million. GSK will pay $1.30 per share for outstanding Genelabs stock. Genelabs will become part of GSK's Drug Discovery organization and its HCV programs will be consolidated with its existing pipeline. The deal will likely close in December.

"Genelabs has demonstrated a strong track record in HCV drug discovery and identified numerous novel classes of inhibitors that target unprecedented mechanisms in the virus's life cycle," stated Zhi Hong, SVP of the Infectious Diseases Centre for Excellence in Drug Discovery at GSK. "This arrangement, combined with our other collaborations, will give GSK a broad HCV drug discovery platform addressing novel targets and innovative therapeutic approaches."

- see GSK's release

Glaxo leaves Exelixis drugs behind as pact ends

John Carroll — Thu, 23 Oct 2008 10:15:47 -0400

Exelixis' six-year collaboration with GlaxoSmithKline has come to the end of the line with Glaxo deciding to bow out without licensing any of the drugs in the program. Exelixis retains the rights subject to a three percent royalty payment on any product that includes XL184, which is beginning a late-stage trial for medullary thyroid cancer. Exelixis says it has had some inquiries on the programs and is exploring its options.

GSK will continue development and commercialization of XL880, a compound developed under the collaboration and previously in-licensed by GSK, with potential additional milestone payments of up to $90 million and double-digit royalty payments to Exelixis on XL880's successful development and commercialization.

"We are pleased to retain the rights to develop and commercialize XL184," said George A. Scangos, PhD, president and CEO of Exelixis. "This compound is our most advanced asset with a promising mechanism of action. It has generated compelling data in patients with medullary thyroid cancer, and data emerging from the phase 2 trial being conducted in patients with glioblastoma also are encouraging. We recently initiated a phase 3 registration trial for XL184 in MTC, and we look forward to the successful progress of this and other trials for the compound."

- read the Exelixis' release

ALSO: Exelixis today reported positive preliminary phase I data from a dose-escalation trial of XL281 in patients with advanced solid malignancies. Release

Glaxo snags Alzheimer's vax rights

John Carroll — Thu, 23 Oct 2008 09:45:20 -0400

GlaxoSmithKline has put down €22.5 million and promised up to €430 million more to license the rights to two early-stage Alzheimer's disease vaccines from Austria's AFFiRiS. Glaxo picks up exclusive rights to two vaccines in Phase I testing and an option on preclinical candidates.

The deal is an endorsement of AFFiRiS' technology. The biotech boasts of being able to design proteins that have very specific binding abilities, a key feature for anyone creating a vaccine that can attack the beta-amyloid associated with Alzheimer's.

"We are impressed with the AFFiRiS technology--combined with our expertise in innovative adjuvant systems--this collaboration will improve our chance of success in the discovery of new treatments against this major disease," said Jean Stephenne (photo), president and general manager of GlaxoSmithKline Biologicals.

- read the joint release

Alcon expand deals with GSK, Origenis

Maureen Martino — Wed, 15 Oct 2008 12:25:38 -0400

Switzerland-based eye care company Alcon has expanded two licensing agreements. First, the company said it would beef up an existing pact with GlaxoSmithKline to include global ophthalmic rights to cilomilast. GSK gets an undisclosed up-front payment in addition to milestone payments, and retains all non-ophthalmic rights to the drug.

In addition to the GSK deal, Alcon expanded its existing drug research alliance with Origenis to discover and develop small molecules that might one day have a role in the treatment of eye diseases. Origenis will earn research and royalty payments; Alcon retains the rights to any products for ophthalmic and nasal applications.

"Alcon's focus is on expanding our research pipeline through targeted collaborations," said Sabri Markabi, M.D. who is Alcon's senior vice president of research and development and chief medical officer. "We believe the cilomilast compound has potential for treating dry eye as well as other ophthalmic conditions. The expansion of our already successful arrangement with Origenis will also help Alcon add more early-stage compounds to our exploratory efforts."

- see Alcon's release for more

Synta earns $25M milestone from GSK pact

John Carroll — Tue, 14 Oct 2008 11:32:18 -0400

Synta Pharmaceuticals has earned a $25 million pay out from GlaxoSmithKline. And it stands to earn another two $25 million checks as Glaxo advances the cancer drug elesclomol, which is in a late-stage study as a treatment for skin cancer. The therapy triggers apoptosis, or programmed cell death.

When Lexington, MA-based Synta signed up on its development pact with Glaxo a year ago, it outlined a set of milestones worth up to $585 million and gained $80 million up front. The deal calls for $145 million in milestones for melanoma and $440 million for other cancer indications. Synta was a 2007 Fierce 15 company.

- check out Synta's release
- read the AP report

GlaxoSmithKline to axe 850 jobs in R&D

Maureen Martino — Wed, 01 Oct 2008 14:04:53 -0400

Moving forward with its restructuring plan, GlaxoSmithKline announced to employees via email today that it would be laying off as many as 850 (6 percent) employees in its research and development units in the U.K. and in the U.S. Although the company has yet to determine exactly how many employees will be laid off, the cuts will be concentrated in its preclinical and early-stage drug development teams, and will include scientists as well as administrative staff. Report

GSK ends NPS's osteoporosis drug study

Maureen Martino — Fri, 26 Sep 2008 09:20:00 -0400

Bad news for NPS Pharmaceuticals: the company announced late Thursday that its partner GlaxoSmithKline would abandon a Phase II study of Ronacalaret, an osteoporosis drug. According to SEC filings cited by the Associated Press, GSK is halting the study because Ronacalaret is not effective. "GlaxoSmithKline has not communicated to the company a decision with respect to their continuation of other research and development activities under the agreement," NPS said in the filing.

GSK and NPS have been partners since 1993, and NPS has received $26.1 million in various milestone payments since then. NPS won't have to return any of that money.

- see the RTTNews article

GSK: Ovarian cancer drug positive in Phase II

John Carroll — Mon, 15 Sep 2008 12:02:49 -0400

GlaxoSmithKline says it will push pazopanib into late-stage studies for ovarian cancer after a mid-stage trial produced positive data on a key biomarker. Only 35 patients participated in the Phase II trial. Close to a third of them reported a greater than 50 percent reduction in CA-125, a protein used to predict the risk of tumors recurring. Like Avastin, the drug is designed to halt the formation of blood vessels that feed the tumors.

"Many patients with ovarian cancer will have a recurrence of cancer following initial chemotherapy," said Prof. Michael Friedlander. "This study clearly demonstrates that pazopanib is an active, well-tolerated drug for women with recurrent ovarian cancer."

- read GSK's release for more info

Related Articles:
GSK founds oncology unit
GSK shakes up R&D

GSK founds oncology unit

Maureen Martino — Fri, 12 Sep 2008 11:04:51 -0400

Last December GlaxoSmithKline said that it had more plans to shake up R&D. The company had already created Centres of Excellence for Drug Discovery (CEDD) and laid off thousands of workers in order to streamline the company. So what's next? A new oncology-focused unit, according to a statement release at the European Society of Medical Oncology meeting.

GSK Oncology, as it will be known, will consolidate small discovery units and a highly specialised drug development group to create an oncology R&D center within the company. Vice President of Oncology R&D Paolo Paoletti (photo) will head the whole thing up.

"The newly formed GSK R&D Oncology Unit is directly aligned with our R&D strategy to deliver more products of value, and will help us increase our efforts towards personalised medicine in oncology," said Moncef Slaoui, Chairman, Research and Development. "This dedicated unit will have the primary goals of identifying new targets and pathways, conducting innovative clinical research and cost-effectively increasing development capacity in order to deliver the unit's large portfolio of medicines." The announcement was made in conjunction with the European Society of Medical Oncology meeting.

- here's GSK's release on the new unit

GSK signs $1.5 drug dev deal with Cellzome

Maureen Martino — Wed, 10 Sep 2008 12:32:06 -0400

GlaxoSmithKline is teaming up with Cellzome, which is developing kinase-targeted drugs, in a deal that could be worth up to $1.5 billion. The pact will target inflammatory diseases such as rheumatoid arthritis or multiple sclerosis. GSK is paying £14.4 million upfront to license drug candidates from Cellzome's kinase programs directed against four identified targets. Three additional targets will be selected by both companies. Cellzome will use its technology to identify small molecule inhibitors for the chosen targets, and then develop the most promising drugs. GSK has first dibs on licensing the products Cellzome develops, but Cellzome will retain rights to the drug candidates if GSK takes a pass.

Cellzome could gain up to £118 million per program in milestones and "double digit royalties" on net sales.

"GSK is committed to becoming a world leader in immuno-inflammation drug discovery by finding transformative medicines through internal efforts and external collaborations," said Jose Carlos Gutierrez-Ramos, head of GSK's Immuno-Inflammation Centre of Excellence for Drug Discovery. "Cellzome's Kinobeads technology will provide a distinct advantage because it uses native kinases directly isolated from human cells and tissues."

This is just one of a number of deals GSK has inked in the last several months. The company has signed deals with Valeant, Harvard, the Disease Institute of Boston and, most notably, a $3.25 billion deal with Actelion. The string of deals reflect the new CEO Andrew Witty's strategic move to look outside the company for innovations in drug technology.

- see GSK's release for details

GSK's Viehbacher picked as Sanofi CEO

Maureen Martino — Wed, 10 Sep 2008 10:28:49 -0400

When GlaxoSmithKline's Chris Viehbacher (photo) announced his plans to leave the company, everyone wondered where he would head next. Apparently it's the CEO spot at another company--the position he was passed over for at GSK. As of December 1, Viehbacher will replace Gerard Le Fur as CEO of Sanofi-Aventis. Article

GSK, Valeant ink $820M epilepsy deal

John Carroll — Thu, 28 Aug 2008 11:38:43 -0400

Valeant Pharmaceuticals will pocket a $125 million upfront fee from GlaxoSmithKline in exchange for a collaboration deal on the epilepsy drug retigabine. Altogether the pact could be worth up to $820 million if the drug achieves all of its milestones. Valeant retains up to half of the profits from any sales in the U.S. and several other countries. Glaxo also gains the rights to VRX698 and the other back-up compounds from the potassium channel opener discovery program.

Retigabine has already completed two Phase III trials and is in a study for post-herpetic neuralgia, a painful complication of shingles. The developers say they will file for European approval in early 2009.

"There is a significant need for novel anti-epileptic drugs, as almost one-third of patients with epilepsy continue to experience seizures despite treatment with currently available medications," commented Steve Stefano, senior vice president, GSK U.S. NeuroHealth Division. "We believe that retigabine could potentially play a significant role in improving the management of epilepsy and is a welcome addition to GSK's portfolio."

- check out the release

Chemists laid off at GlaxoSmithKline

Maureen Martino — Wed, 06 Aug 2008 12:04:45 -0400

GlaxoSmithKline's June announcement that it was cutting 350 jobs worldwide is coming to fruition. The company just laid off 22 scientists at its Medicinal Chemistry and Oncology Department in Research Triangle Park, North Carolina. Report

GSK, Genmab report strong ofatumumab data

Maureen Martino — Fri, 01 Aug 2008 09:01:06 -0400

So far, it looks like GlaxoSmithKline's $2.1 billion deal for HuMax-CD20 was money well spent. Inerim data from a Phase III study showed that the drug--now known as ofatumumab--met primary and secondary endpoints in two groups of chronic lymphocytic leukemia patients who did not respond to either methotrexate or TNF-alpha antagonist therapy. More than half of the subjects who received ofatumumab responded to the drug, and now the companies are hoping to submit the drug the FDA and EMEA this year. The drug is also being studied in patients with non-Hodgkin's lymphoma, rheumatoid arthritis and multiple sclerosis.

- see this release on the results
- here's the WSJ report

GSK, Harvard ink stem cell research pact

Maureen Martino — Fri, 25 Jul 2008 12:30:04 -0400

In another instance of the industry teaming up with academia, GlaxoSmithKline and Harvard Stem Cell Institute (HSCI) announced that they have signed a five-year, $25 million pact to research and possibly develop stem cell drugs. GSK will fund HSCI's research in several areas, including neuroscience, heart disease, cancer, diabetes, musculoskeletal diseases and obesity. The company will also fund an annual grant, which supports early stage research in stem cell biology.

Part of the draw for GSK, apparently, is the concentration of skilled biotech workers in the Boston area. "We have carefully chosen the Boston biomedical community to collaborate with on this important venture. It has the highest concentration of leading stem cell scientists, and the Harvard Stem Cell Institute is the epicenter of that community," said Patrick Vallance, GSK's drug discovery chief. The Boston Globe notes that the deal is one of the largest stem cell investments ever made by a Big Pharma company.

- see this GSK release
- read the Boston Globe's report

GSK chief elaborates on biotech strategy

John Carroll — Thu, 24 Jul 2008 11:13:43 -0400

With profits sliding, GlaxoSmithKline CEO Andrew Witty used much of his second quarter review for analysts to amplify plans to radically alter its R&D work, abandoning its old focus on blockbusters in favor of more targeted drugs that earn more modest incomes. Glaxo is shifting more to a biotech approach, creating small units of up to 80 scientists to pursue development programs. Those groups will then apply for research funds from a central investment board.

According to a report in The Times, Witty plans to also set up a venture arm to invest in promising new therapies pursued by early-stage companies or set up small companies to focus on Glaxo drugs. In addition, the pharma giant plans to coordinate their research with UK regulatory officials to help determine if the drugs they have in development are cost efficient and unique. And Glaxo is delaying a share buyback plan to make sure that the company has the funds it needs to make new acquisitions.

- read the report from The Times
- read the story in the Wall Street Journal

ALSO: GlaxoSmithKline and the Harvard Stem Cell Institute have inked a five-year, $25 million-plus collaborative agreement to build a "unique alliance in stem cell science, leading to the development of new medicines." Release

Theravance wins $10M milestone on Phase II data

John Carroll — Tue, 15 Jul 2008 11:49:40 -0400

Mid-stage data from an experimental COPD therapy under development by GlaxoSmithKline researchers came in positive, and that will be worth a $10 million milestone payment for Theravance. Theravance discovered GSK961081 (081), which researchers say was well tolerated in the study with no serious side effects.

"We are very encouraged by the results of this study," said Rick Winningham, CEO of Theravance. "'081 is the first compound studied in COPD patients that combines the activity of both a beta2 agonist and a muscarinic antagonist in a single small molecule. We believe that this compound may provide a new monotherapy treatment option for the increasing number of patients living with COPD, or potentially as combination therapy with an anti-inflammatory medication."

Theravance separately announced that an early stage trial of GSK1160724/TD-4208 demonstrated that the drug was generally well tolerated at all doses tested. In addition, TD-4208 showed the potential for 24-hour bronchodilation in COPD patients. That's also good news for Theravance, which was recently notified that it is getting the development program back from Glaxo and is now looking for a new partner for the program.

- check out the trial results
- and also this release
- read the AFX report

GSK inks $3.25B insomnia pact with Actelion

John Carroll — Mon, 14 Jul 2008 12:48:46 -0400

GlaxoSmithKline has partnered with Actelion in a whopping 3.3 billion Swiss franc pact ($3.25 billion) covering a new insomnia therapy now in late-stage studies. Actelion nabs 150 million francs upfront with 415 million more dependent on the Phase III data. Shares of Actelion swiftly shot up after the Swiss developer announced the news concerning almorexant. Another 2.7 billion francs in additional milestone payments is up for grabs depending on the drug's performance against insomnia and two other "major indications." GSK will also pay for 40 percent of the remaining development costs for the drug, which Actelion will continue to shepherd.

That's a big win for Actelion, which has been developing the orexin receptor antagonist. GSK acquires the worldwide rights to almorexant outside Japan. GSK has also been developing an orexin antagonist, though PharmaTimes notes that the program appears "stalled."

- see GSK's release
- here's the AFP story
- read the PharmaTimes report