Notable regulatory events over the Christmas period

EP Vantage brings you notable regulatory events that you may have missed over the Christmas break.

December 24

Takeda’s new anti-diabetic agent, alogliptin, a DDP-IV inhibitor in the same class as Merck & Co’s Januvia, suffered a significant regulatory setback with news that the FDA has revised its PDUFA date to June 26, 2009, an eight-month delay to the original action date of October 27, 2008.

Although Takeda’s shares were largely unaffected by the news on the assumption the delay is purely due to staffing shortages at the FDA rather than any issues with the NDA, as the company’s most valuable pipeline or marketed drug, currently valued at $5.97bn according to EvaluatePharma’s NPV Analyzer, the final verdict on alogliptin in June is likely to be one of the most significant events in 2009 for the Japanese pharma giant (Alogliptin PDUFA crucial to Takeda, October 8, 2008).

December 26

GlaxoSmithKline and partner Eurand announce that a complete response letter was received for EUR-1048, a taste-masked, orally disintegrating tablet formulation incorporating a Glaxo proprietary active ingredient that has been developed using Eurand’s technologies. The letter must have been received some time ago, as Glaxo submitted its response on December 24, and has told Eurand it expects that the FDA will take up to 60 days to review the response and take action. Separately, the FDA also has advised GSK that the review of another collaborative product, EUR-1000, has been extended into 2009. EUR-1000 is a generic equivalent to the betablocker Inderal LA.

Allergan got a wink from the US regulators who approved Latisse, the group’s one-a-day topical product to promote eyelash growth. The product, whose active ingredient is, bimatoprost, was originally used as treatment for glaucoma under the name Lumigan, before doctors noticed that one of the side effects of the treatment was longer and thicker eyelashes. Lattise has been approved for the condition hypotrichosis of the eyelashes, but many believe it will be used cosmetically.

December 29

Intercell admitted that an FDA decision on Ixiaro, the Austrian company’s new Japanese Encephalitis vaccine, hoped to be announced by the end of 2008, is now expected in early 2009.

The indicators towards FDA approval remain encouraging following recent positive reviews in Europe and Australia, but full US approval of Ixiaro is vitally important to the company; royalties from worldwide partner Novartis are forecast to reach $235m by 2014, valuing the vaccine at $1.32bn to Intercell or almost all of the group’s market capitalisation of $1.43bn.

Ferring Pharmaceuticals received FDA approval for degarelix, a gonadotropin releasing hormone (GnRH) receptor inhibitor, to treat patients with advanced prostate cancer, representing a first new drug in several years for prostate cancer.

Savient Pharmaceuticals' shares rose by 20% on the news that the FDA had accepted its BLA and was granting priority six-month review for its gout product Puricase. The drug, which is filed for use in patients who have failed on other gout treatments, is now expected to have a PDUFA date of April 30, 2009.

Salix Pharmaceuticals received a non-approvable letter for Balsalazide, a treatment for mild to moderate ulcerative colitis, sending its shares down by 5%. The regulator also called for what will be costly additional clinical trials. In response Salix said it did not intend to conduct additional trials and would be meeting with the FDA in the next 30 days to discuss the application. Balsalazide, is a higher dose formulation of Colazal, the group’s former best selling drug that earlier this year succumbed to generic competition.

Ipsen’s most valuable drug, Dysport, a botulinum toxin similar to Allergan’s Botox, received a minor setback with a complete response letter to the company’s application to market the product for cervical dystonia in the US. Importantly, no additional clinical data has been asked for and Ipsen expects to file its response during the first quarter of 2009.

December 30

Northfield Laboratories’ application for PolyHeme, a blood substitute product, was formally accepted by the FDA and granted priority review status, with a PDUFA date of April 30, 2009.

As Northfield’s only product in development, with a long and chequered developmental and regulatory history having already been rejected by the FDA back in November 2001, and with limited cash reserves, the current review of PolyHeme represents a last throw of the dice for the company.

GTx reached an important regulatory milestone with the filing of toremifene, an oral selective estrogen receptor modulator (SERM), for the prevention of bone fractures in men with prostate cancer on androgen deprivation therapy.

Currently expected to market the drug themselves in the US, consensus forecasts for the drug in 2014 sit at $276m, valuing the drug at $462m or almost all of GTx’s enterprise value of $517m.

December 31

One of the most disappointing regulatory setbacks of 2008 concerned Eli Lilly and Daiichi Sankyo’s anti-clotting agent prasugrel, a potential competitor to one of the industry’s biggest-selling drugs in Plavix, which missed two PDUFA action dates in June and September and confusion reigned in the absence of a formal advisory committee review.

However, much-needed clarity over the drug’s commercial prospects look set to be available soon with news that the FDA has decided its cardiovascular and renal drugs advisory committee (CRDAC) will review prasugrel on February 3, 2009.

Just one day after King Pharmaceuticals’s acquisition of Alpharma, King announced that the FDA’s review of Embeda, one of Alpharma’s most valuable drugs, is now likely to extend into early 2009.

Predicting the outcome of the FDA’s review of Embeda, an abuse-resistant formulation of morphine, is extremely difficult given the mixed and cautious conclusions by an advisory committee in November (Alpharma hoping Embeda's small advance is sufficient, November 17, 2008).

Labopharm won US approval for Ryzolt, a once-a-day formulation of the painkiller tramadol, sending the Canadian company’s shares leaping 33%. Marketing partner Purdue Pharma will launch the tablet in the second quarter of 2009.

January 2

In keeping with the sudden rush of applications to sell abuse-resistant formulations of opioid drugs, King Pharmaceuticals and Acura Pharmaceuticals announced the filing of Acurox, an immediate release formulation of oxycodone which applies Acura’s Aversion technology to deter drug abuse.

Although King is expected to book relatively modest sales of Acurox, $76m by 2014, approval of the drug will provide vital validation of Acura’s technology platform.

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