Key regulatory events for the next six months in Q3 and Q4 in 2012

The hype and excitement around Biogen Idec’s treatment BG-12 for multiple sclerosis is set to come to a head with widely expected fourth quarter approval in both the US and Europe. Although BG-12 is set to be one of the biggest drug launches this year, there are also others in the midcap world expecting decisions that could have an even greater an impact on their shares and future

The other big events include Medivation and Astellas Pharma’s US approval of prostate cancer drug enzalutamide (MDV3100); Amarin getting a decision in the US on cholesterol treatment AMR101 that would help its patent position; and both European and US approval of linaclotide from Ironwood Pharmaceuticals and Forest Laboratories, two companies under pressure and in desperate need of some good news (see table).

Moving to the front

Big things are predicted for BG-12, which is not only the biggest growth driver at Biogen, but also the group’s most valuable product, with a NPV of $11bn. Sales are expected to hit $3.42bn by 2018 (Confirm shows BG-12 potential, October 26, 2011).

If the drug is approved by the December 28 PDUFA action date in the US, the big debate will be at which stage of the disease BG-12 will be used. Some in the industry are expecting doctors could move it straight to frontline treatment. Whatever stage it is used, with its superior efficacy it is almost certainly going to erode sales of current oral incumbent Gilenya, which has been hit by safety scares following unexplained cardiovascular deaths.

For most companies securing approval is the end of their troubles; for Amarin, this is just one more bridge crossed before it can finally relax. The FDA is set to rule on the group’s triglyceride-lowering drug, AMR101, by July 26, but for Amarin the most important task is strengthening the intellectual property around the fish oil treatment (Event – US filing is only part of the Amarin puzzle, July 06, 2012). What Amarin will most desire is that the FDA decides AMR101 is a new molecular entity, a ruling expected a month after the PDUFA decision and one that should give AMR101 and its shaky patents three to five years of protection from generic competition. 

Forest in particular will be hoping that all goes well when its drug for irritable bowl syndrome with constipation, linaclotide, is up before the US regulators on September 7. Forest is currently reeling from a the patent expiry of anti-depressant Lexapro, that has forced it to cut its growth forecasts for the year and on Tuesday report a 79% fall in quarterly earnings. But the PDUFA date, which was delayed by three months, may not save Forest’s board, which is under attack from activist shareholder Carl Icahn. A showdown is expected at the August 15 annual board meeting.

Share price rise

Growing expectations about prostate cancer drug and US marketing authorisation in the fourth quarter are behind the more than doubling of Medivation shares since the beginning of the year. The drug has shown impressive results in clinical trials, leading to the early halt of its phase III Affirm trial (Medivation roars back to life as prostate cancer drug delivers, November 3, 2011). Despite the stop the drug is believed to have clear survival benefits. Sales for partner Astellas are forecast to reach $1.12bn fueled by its efficacy and the fact that unlike its nearest competitors it is a monotherapy.

Having been another victim of the FDA’s decision to extend the review time of their drug, Relistor, Progenics Pharmaceuticals and Salix Pharmaceuticals are expecting to find out by July 27 if their oral version of opioid induced constipation drug Relistor will pass muster. If the oral formulation is approved it would continue the turnaround for Progenics, which was sparked by the release of positive top line data in December (Progenics' Relistor moving nicely through trial success, December 21, 2011). Approval would also open up a new and much bigger patient population in the form of patients with chronic non-cancer pain. 

The table below highlights some of the biggest regulatory decision facing the industry, outside of big pharma.

Regulatory decisions    
Product Company Pharmacological Class Event Indication Date Product  NPV ($m) NPV as % of Market Cap
BG-12 Biogen Idec Fumarate EU and US approval MS Q4 9,148 27%
Eylea Regeneron Pharmaceuticals VEGFr kinase inhibitor EU and US approval Wet AMD (EU), CRVO (US) Q3, 23 Sep 6,312 59%
AMR101 Amarin Omega-3 fatty acid US approval Hypertriglyceridemia 26 Jul 2,776 161%
MDV3100 Medivation Androgen receptor antagonist US approval Prostate cancer Q4 2,472 78%
MDV3100 Astellas Pharma Androgen receptor antagonist US approval Prostate cancer Q4 2,016 11%
Kyprolis Onyx Pharmaceuticals Proteasome inhibitor US approval Multiple myeloma 27 Jul 2,305 80%
Qsymia (Qnexa) VIVUS Adrenoreceptor agonist & anti-convulsant EU approval Obesity Q4 2,157 80%
Adcetris Seattle Genetics Anti-CD30 MAb-auristatin E conjugate EU approval Hodgkin lymphoma and systemic anaplastic large cell lymphoma Q3 1,765 60%
Linaclotide Ironwood Pharmaceuticals Guanylate cyclase type-C receptor agonist EU and US approval IBS Q3, 7 Sep 1,130 52%
Linaclotide Forest Laboratories Guanylate cyclase type-C receptor agonist US approval IBS 7 Sep 1,083 12%
Linaclotide Almirall Guanylate cyclase type-C receptor agonist EU approval IBS Q3 114 9%
Gattex NPS Pharmaceuticals GLP-2 agonist US approval Short bowel syndrome 30 Sep 987 163%
Omontys Affymax Erythropoietin stimulator EU approval Anemia Q3 854 178%
Ocriplasmin ThromboGenics Plasmin Ad Com, EU and US approval VMA 26 Jul, Q4, 17 Oct 755 79%
Relistor Progenics Pharmaceuticals Mu opioid antagonist US approval Opoid induced constipation 27 Jul 733 250%
Lyxumia Zealand Pharma GLP-1 agonist EU approval Diabetes Q4 649 198%
Cabozantinib Exelixis VEGFr2, RET & Met tyrosine kinase inhibitor US approval Thyroid cancer Q4 618 80%
IPX066 IMPAX Laboratories Dopamine precursor & dopa decarboxylase inhibitor US approval Parkinson’s disease Q4 581 38%
Kynamro Isis Pharmaceuticals Apolipoprotein B-100 antisense EU approval Familial hypercholesterolaemia Q3 538 49%
Eklira Forest Laboratories LAMA US approval COPD 30 Jul 308 3%
DR Cysteamine Raptor Pharmaceutical Lysosomal transport modulator EU and US approval Nephropathic cystinosis Q4 297 106%
Budesonide MMX/Uceris Cosmo Pharmaceuticals Corticosteroid EU and US approval Ulcerative colitis Q3, Q4 194 52%
Budesonide MMX/Uceris Santarus Corticosteroid US approval Ulcerative colitis Q4 174 38%
Lomitapide Aegerion Pharmaceuticals Microsomal triglyceride transfer protein inhibitor EU approval Homozygous familial hypercholesterolemia  Q4 135 37%
UT-15C Sustained Release United Therapeutics Prostacyclin analogue US approval PAH 27 Oct 124 5%
Selincro Lundbeck Opioid antagonist EU approval Alcohol dependence Q3 72 2%
Crofelemer Salix Pharmaceuticals CFTR channel & calcium-activated chloride channel blocker US approval HIV-associated diarrhea 5 Sep 54 2%
Zaltrap Regeneron Pharmaceuticals VEGFr kinase inhibitor EU and US approval Colorectal cancer Q3 21 0%
Scenesse Clinuvel Pharmaceuticals Melanocortin receptor agonist EU approval Erythropoietic protoporphyria Q3 - -
Selincro Biotie Therapies Opioid antagonist EU approval Alcohol dependence Q4 - -

Data source: EvaluatePharma's Calendar of Events.

To contact the writers of this story email Lisa Urquhart or Joanne Fagg in London at [email protected] or [email protected]

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