Replies to post #77824 on Biotech Values

[DewDiligence]

MDCO – Now we know why AZN was willing to part with Cangrelor so cheaply.

[DewDiligence]

To evaluate MDCO, one needs to form an opinion about the likelihood
and timing of a US generic for Angiomax after patent protection ends
in 2010. MDCO and sell-side analysts speaking on the company’s behalf
assert that the difficulty of Angiomax manufacturing will keep generics
at bay, but this does not ring true, IMHO. Comments?

http://www.reuters.com/article/marketsNews/idINBNG41244420090513

Medicines Co. Stops Cangrelor Trials; Shares Tank

›Wed May 13, 2009 4:28pm EDT
By Shailesh Kuber

BANGALORE, May 13 (Reuters) - Medicines Co (MDCO) pulled the plug on the development of an experimental treatment to prevent blood clotting during angioplasty as it is not expected to meet its main trial goal, sending the stock crashing as much as 45 percent.

However analysts said the sell-off was overdone as the drug developer had other promising candidates, and the stock fall could prove attractive to would-be acquirers.

"If Medicines remains at its current value of about $6-$7 per share, we believe the company could be an attractive take-out candidate for big pharma or other companies with sales in acute care," Wedbush analyst Liana Moussatos said.

Shares of the company, the biggest percentage loser on Nasdaq Wednesday, closed down 37 percent at $7.02. They hit a more than seven-year low of $6.15 earlier in the day.

Medicines discontinued late-stage trials of the antiplatelet agent cangrelor in patients undergoing procedures to widen narrowed arteries, as the intravenously administered drug showed no real difference in effectiveness compared with the oral drug Plavix.

Discontinuation of the program will result in cost savings of about $5 million in 2009, the company said.

Antiplatelets like Bristol-Myers Squibb Co's and Sanofi-Aventis SA's blockbuster Plavix work by stopping platelets -- tiny blood cells vital for the normal clotting process -- from clumping together and forming life-threatening clots in arteries.

Plavix has annual sales of around $8 billion.

Medicines said it will now accelerate development of cangrelor as a replacement for Plavix in patients requiring cardiac surgery but cannot take that drug due to a risk of bleeding.

Cangrelor was licensed from AstraZeneca in December 2003.

STOCK OVERSOLD

"We believe it is not game over for Medicines Co. Cangrelor may work as a bridge to cardiac surgery and Oritavancin may be successful as an acute care antibiotic," Wedbush's Moussatos said.

Oritavancin is the company's antibiotic candidate for the treatment of infections such as the deadly MRSA.

She raised the Medicines stock to "buy" from "hold" saying the stock was oversold on reaction to cangrelor.

Moussatos projected peak annual sales of about $70 million for Cangrelor if the alternate indication was successful and estimated peak annual sales of about $100 million for Oritavancin.

In reiterating his "outperform" rating on the stock, Leerink Swann analyst Joseph Schwartz said the market was not accurately valuing the opportunity of Angiomax, an anti-coagulant already marketed by the company for use in patients undergoing coronary angioplasty.

Angiomax, which goes off patent in March 2010, but for which the company retains pediatric exclusivity till September 2010, had U.S. sales of $334.2 million in 2008.

"After patent exclusivity ends, we believe Angiomax will only have a limited number of generic threats given the extremely difficult manufacturing process, which will encourage more rational generic pricing," Schwartz said in a note.

He however cut his fair value estimate on the stock to $11 from $20 due to removal of cangrelor from the brokerage's model.‹

[DewDiligence]

Cangrelor Can Still Succeed—Maybe

[These are post-hoc subset data subset data from the two phase-3 Cangrelor trials in PCI that were stopped in May 2009 by the DSMB due to futility: one tested Cangrelor vs Plavix and the other tested SoC ± Cangrelor (#msg-37803743). The comments below from the PI of one of the two failed trials strike me as unduly bullish on the drug’s prospects.]

http://www.reuters.com/article/marketsNews/idCNN1518391020091115

›Sun Nov 15, 2009 2:22pm EST
By Ransdell Pierson and Bill Berkrot

ORLANDO, Fla., Nov 15 (Reuters) - An experimental Medicines (MDCO) Co blood thinner that failed two late-stage clinical trials earlier this year still holds great promise and deserves to be tested in new studies, researchers said on Sunday.

The company discontinued two large trials of the intravenous drug, called cangrelor, in May after an independent monitoring board deemed it unlikely to prove to be superior to the widely used pill Plavix.

Cangrelor had been tested against Bristol-Myers Squibb Co's (BMY) Plavix among patients undergoing procedures to clear their heart arteries of plaque, to see if it was better within 48 hours at reducing incidence of death, heart attack or a need for new heart procedures.

Cangrelor failed the trials because it was not satisfying that combination of study goals, or endpoints. Even so, it sharply reduced overall mortality and the occurrence of blood clots associated with new stents, researchers said.

Some 0.7 percent of patients taking Plavix by itself died within 48 hours of treatment, compared with 0.2 percent of those who received cangrelor in combination with Plavix, representing a 67 percent reduction for the cangrelor group.

Clotting from stents was reduced from 0.6 percent in the Plavix group, to 0.2 percent of those taking both cangrelor and Plavix, and the reduced clotting may help explain the lower death risk, researchers said.

The data were presented at the American Heart Association scientific meeting in Orlando.

Dr. Deepak Bhatt, chief of cardiology at the Veterans Administration Boston Healthcare System -- who helped lead one of the two large failed trials -- said he believes Medicines Co will likely conduct new big trials of cangrelor in view of the favorable secondary data on survival and stent blood clots.

"I think it should be tested again in large Phase III trials because there is a clinically meaningful benefit" in those secondary trial goals, even though the earlier studies failed to achieve their combined main goals.

Bhatt and other researchers said cangrelor may post better results if patients receive longer intravenous infusions, should new trials commence.

He said an older clot preventer, Merck & Co's (MRK) Integrilin, failed initial trials only to succeed in later studies after its dosage was increased.

Cangrelor belongs to a newer class of agents that includes Plavix, Eli Lilly's (LLY) Effient and AstraZeneca Plc's (AZN) Brilinta. They use the same mechanism to prevent blood cells called platelets from clumping together to form clots, and all are pills, with the exception of cangrelor.

"Cangrelor is the only intravenous one of them, which becomes an appealing feature when patients can't take pills because they are vomiting, or are on a ventilator or sedated," Bhatt said.

Moreover, he said cangrelor takes effect very quickly and unlike Plavix, its blood-thinning effects can be quickly reversed if doctors need to perform major surgery.

An editorial in the New England Journal of Medicine suggested that the failure of the earlier studies may have been due more to trial design than to a failure of cangrelor, which it called a potent medicine "with rapid onset and offset of action."

"These valuable qualities certainly warrant further study aimed at identifying more suitable clinical niches for cangrelor and more appropriate approaches to its use," the editorial concluded.‹