GlaxoSmithKline plans to end 2006 with six product launches and six regulatory filings, CEO J.P. Garnier said during a presentation at the Bear Stearns Healthcare conference in New York Sept. 13.

Garnier touted GSK's pipeline as the largest in the pharmaceutical industry based on benchmark studies, with the 140 projects in the clinic comprising a balance of new chemical entities, line-extensions and vaccines.

"Remember, we came from nowhere," Garnier said. "Four or five years ago, we were in the back of the pack, but the transformation of the R&D process which we had undertaken five to seven years ago has paid off in spades, and now we have been able to double the size of our portfolio in only four years."

"We have a number of very innovative drugs, best in class, pioneer drugs, but it is also a pipeline which has some low-risk projects, vaccines, important commercial line extensions and the like," he noted.

Garnier emphasized the breadth of the company's Phase II pipeline during the company's most recent quarterly earnings call (¹ [A#00670310009], p. 15).

"This is not anymore an early stage pipeline, it's a near term pipeline," he added (see chart: " ² GlaxoSmithKline's Devilish Plan ").

Among the new products slated to launch next year is Entereg (alvimopan), a postoperative ileus therapy being co-developed with Adolor. The drug was deemed "approvable" by FDA in July, but the agency requested additional proof of efficacy to support the use of the drug following bowel resection surgery, the proposed indication. The additional clinical data should be available in "early 2006," according to Garnier.

Upcoming launches also include the line extensions Avandaryl , Trexima and Coreg CR , all of which have "significant commercial potential," Garnier said.

Coreg CR is a controlled-release version of the beta-blocker carvedilol, while the migraine therapy Trexima is a combination of GSK's Imitrex (sumatriptan) and naproxen being co-developed with Pozen.

Pozen submitted an NDA for the migraine combo in August; Trexima's estimated user fee deadline is June 8, 2006 (³ Also see "Migraine Two-Hour Pain Response Efficacy Standard Suggested By Committee" - Pink Sheet, 8 August, 2005., p. 10).

The company predicted in April that approval of the diabetes therapy Avandaryl (rosiglitazone/sulphonylurea) would occur on schedule at the end of the year despite a good manufacturing practices consent decree for its Cidra, Puerto Rico plant, the facility producing the drug (⁴ Also see "Avandaryl Approval On Track Despite Consent Decree, GSK Says" - Pink Sheet, 2 May, 2005., p. 4).

A delay in the Avandaryl launch would add to the woes GSK is experiencing as a result of the Cidra manufacturing violations. The company lost significant revenues because of FDA's seizure of Paxil CR (paroxetine controlled-release) and Avandamet (rosiglitazone/metformin) in March.

More recently, the company informed Canadian wholesalers and pharmacists that it would be unable to fill orders of Coreg, Paxil and Relafen until the end of the year as a result of the manufacturing issues (⁵ Also see "GSK Informs Canadian Wholesalers Of Coreg, Paxil, Relafen Shortages" - Pink Sheet, 19 September, 2005., p. 23).

The other two launches anticipated next year are the rotavirus vaccine Rotarix in Europe and the OTC launch of the obesity agent Xenical (orlistat), for which GSK filed an Rx-to-OTC switch application in June.

In addition to the launches, GSK is gearing up for half a dozen regulatory submissions next year. The company plans to file applications with FDA for the human papilloma virus vaccine Cervarix , the breast cancer agent lapatinib and the oral low platelet therapy 497115.

The drug maker has been bulking up its vaccine business and it plans to introduce five new vaccines within five years. The firm recently took steps to strengthen its flu vaccine portfolio with the planned acquisition of Fluviral manufacturer ID Biomedical (⁶ Also see "GSK Vaccine Portfolio Gets A Shot In The Arm From ID Biomedical Buy" - Pink Sheet, 12 September, 2005., p. 22).

The lapatinib filing could take place in the fourth quarter of 2006 or early 2007, while the 2006 filing schedule for '115 assumes favorable Phase IIb study results, Garnier noted.

Other filings will aim to address generic competition, including Allermist for the treatment of allergic rhinitis, which is intended to replace the off-patent intranasal steroid Flonase (fluticasone).

GSK also is planning to file Lamictal XR , a once-daily version of its anti-epileptic lamotrigine, which is protected by a method-of-use patent expiring in July 2008. While Teva already won the right to introduce a chewable version of Lamictal more than three years ahead of the patent expiration, the bulk of GSK's sales come from the non-chewable tablet version of the drug.

GSK intends to file for approval of the antidepressant Wellbutrin XL (bupropion extended-release) in Europe, a market that represents a "big opportunity" because Wellbutrin is not currently available in Europe, Garnier said.

The company separately announced Sept. 15 that it is terminating clinical studies of the investigational HIV therapy aplaviroc in treatment-naïve patients after receiving reports of severe hepatotoxicity. GSK said it made the decision to halt the Phase IIb trials after reviewing the liver toxicity findings with FDA.

"While we are stopping our work in treatment-naïve patients, we are proceeding cautiously with treatment-experienced HIV patients who need new treatment options," the company said.

GSK is amending its aplaviroc Phase III protocol, evaluating the CCR5 entry inhibitor in treatment-experienced HIV patients and implementing additional safety monitoring requirements as well as making changes to patient inclusion/exclusion criteria, the company reported.

Pfizer is also evaluating the CCR5 inhibitor class for the treatment of HIV; CEO Hank McKinnell recently said Pfizer would put $500 mil. behind its own potential CCR5 inhibitor maraviroc, now in Phase III development.

GSK’s Six Launches, Six Filings Slated For ’06: Sign Of R&D Strategy Payoff?

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