INCY估值有遗漏?

JPM has a $16 yr end target. The JPM report is quiet favorable (recent weakness a buying opportunity, usual blah, blah).

In the JPM valuation model, the main driver is the 424 program for MF. JPM assigns a 70% probability of approval, with peak sales in 2015 at $500 mn/yr. By contrast, at the Cowen conference last month, INCY mgnt gave a range of $640-940 mn/yr for MF sales.
The other driver in the JPM model is 050, which they assign a 30% probability of approval, with $1 bn in peak sales in 2020.

In JPM model, I don't see any value assigned to PV or ET. It seems to me that the probability of approval is higher, and the probable timing of approval sooner, for 424 in PV than for 050 in RA. INCY/NVS could start at phase 3 trial for PV in Q3, which would put PV about one yr behind MF. The potential market for PV/ET is about 2X that of MF, according to the company's projection at the Cowen conference. PV and ET and MF have orphan drug status.

from Yahoo Message Board

贝克兄弟增持SGEN,VPHM

Baker Bro. Buys $7M Worth of SGEN 5/6/2010

Baker Bro. Buys $16M Worth of Viropharma and $3.9M Worth of SGEN 5/5/2010

Baker Bro. Buys $25M Worth of Viropharma 5/3/2010

Targacept reports $6.8M profit

The Business Journal of the Greater Triad Area

Targacept's big licensing and development deal with pharmaceutical giant AstraZeneca pushed the Winston-Salem biotech firm to a $6.8 million profit in the first quarter, according to an earnings announcement.

That compares to a loss of $4.7 million in the first quarter of 2009. The profit stems mainly from the recognition of $17.9 million of revenue in the quarter from the $200 million upfront payment from AstraZeneca to gain access to a drug designed to fight severe depression.

The two companies are also working together on drugs targeting other diseases including Alzheimer's, attention deficit/hyperactivity disorder and schizophrenia.

The company has a separate deal with GlaxoSmithKline for research into Parkinson's disease.

A string of research milestones and lucrative development deals has boosted Targacept's stock price from around $2.40 last July to nearly $24 as of Wednesday's market close.

Incyte arthritis drug shows promise, triggers milestone

Thu, May 6 2010

* Mid-stage data shows drug safe and effective

* Positive data triggers $30 mln milestone from Eli Lilly

* Posts narrower-than-expected Q1 loss

May 6 (Reuters) - Biotechnology firm Incyte Corp said data from a mid-stage trial of its experimental rheumatoid arthritis treatment showed the drug was safe and effective.

The company, which also posted a narrower-than-expected quarterly loss, raised its 2010 revenue outlook to reflect a $30 million payment from Eli Lilly related to the drug INCB28050, and a $3 million milestone from Pfizer Inc for another drug program.

The three-month results from the ongoing six-month trial on 125 rheumatoid arthritis patients showed that the three doses of the drug improved the scores of certain standard measures, like ACR1 and ACR20, for the severity of the disease.

At 12 weeks of treatment with the drug, patients on ACR20, 50 and 70 had response rates of up to 60 percent, 36 percent and 16 percent, respectively, while those on a dummy drug had response rates of 32 percent, 13 percent and 3 percent, respectively.

ACR1 scores also improved rapidly at all three doses -- 4 mg, 7 mg and 10 mg.

The drug was generally well tolerated with one serious adverse event of an unrelated gastrointestinal bleed, the company said in a statement.

Net loss for the first-quarter was $35.7 million, or 30 cents a share compared with a loss of $40.0 million, or 41 cents a share, a year earlier.

Revenue rose to $17.3 million for the quarter, from $671,000 in the year-ago quarter.

Analysts on an average expected the company to post a loss of 33 cents a share, on revenue of $16.1 million, according to Thomson Reuters I/B/E/S.

2010 revenue is now expected to be in a range of $99 million to $101 million, up from the prior view of $66 million to $68 million.

Shares of the Wilmington, Delaware-based company closed at $13.06 Wednesday on Nasdaq. (Reporting by Esha Dey in Bangalore)

UPDATE 1-InterMune shares tank on doubts of lung drug's future

Wed, May 5 2010

(Recasts; adds analysts comments, updates stock movement)

By Krishnakali Sengupta

BANAGALORE, May 5 (Reuters) - Shares of InterMune Inc crashed 78 percent after U.S. health regulators declined to approve its lung drug, raising doubts about the drug's future.

The company will have to decide whether to pursue development of the drug, pirfenidone, which would require an expensive new trial and several more years of investment, or concentrate its developmental efforts on more viable products.

Late Tuesday, InterMune said the U.S. Food and Drug Administration sought a new study to prove the drug's efficacy in treating idiopathic pulmonary fibrosis, a rare, fatal condition in which the lungs suffer scarring due to unknown causes. [ID:nSGE6430LX]

"We felt that the odds of approval were favorable given there are no approved products for this deadly disease, its orphan designation ... and the FDA's body language throughout the panel meeting," analyst Aaron Reames of Wells Fargo Securities said in a note Wednesday.

An FDA advisory panel had recommended the approval of the drug in March by a 9-3 margin. [ID:nN09248590]

However, Jefferies & Co analyst Eun Yang, who had predicted an FDA denial, said it was clear from the March meeting that the regulator did not like the results of the main goal of the study.

The panel had only been 7-5 in favor of finding that InterMune's data showed "substantial evidence" of a meaningful benefit. Dissenters worried that the drug appeared to work only in certain patients and its widespread use could expose a larger population of IPF patients to "risks without benefits."

On Tuesday, InterMune said it will have a follow-up meeting with the FDA over the next 60 to 90 days to discuss what the regulator would specifically like to see in a confirmatory study.

UNCERTAIN FUTURE

Most analysts were concerned about the timing, duration, size and cost of an additional trial.

Katherine Xu of Wedbush Securities Inc said though the company would not provide much details about the new study before its meeting with the FDA, going into another study will cost the company in "tens of millions".

Lazard Capital Markets' Terence Flynn estimates the cost of another trial could exceed $75 million, but still has a "buy" on the stock, as he sees the drug eventually gaining approval in the European market.

Oppenheimer & Co analyst Brian Abrahams also sees a possible European approval for the drug, though not before the first half of 2011.

To pay for the new trial, Abrahams said InterMune will probably restructure its development agreement with Roche Holding AG on its hepatitis C drug ITMN-191.

"We estimate (a restructuring) would lower InterMune's R&D spend by approximately $17 million to 20 million annually, and also InterMune's potential future royalties on the (Hep C) drug," Abrahams, who downgraded the stock from "outperform" to "perform, said.

Given the uncertain outcome of an additional study and the related funding risk, Jefferies' Yang said it won't be surprising if the company decides to end the pirfenidone program altogether.

Yang maintained an "underperform" rating and a price target of $6 on the stock.

InterMune shares were down $35.79 at $10.65 in afternoon trade. They had earlier touched a low of $9.75 Wednesday on Nasdaq.

Analyst Xu, who cut the stock to "neutral" from "outperform said a pirfenidone suspension may force InterMune to partner on other people's product, given the company's lack of a strong pipeline.

Apart from pirfenidone and the hepatitis C drug, InterMune has next generation versions of both drugs in the pre-clinical stage. (Reporting by Krishnakali Sengupta in Bangalore; Editing by Anthony Kurian)

Dendreon Got Big OK, But Still Faces Hurdles

By PETER BENESH, INVESTOR'S BUSINESS DAILY

Posted 05/05/2010 06:20 PM ET

View Enlarged Image

Regulatory approval of Dendreon's (DNDN) prostate cancer treatment, Provenge, marked a huge advance for the company and perhaps for the drug industry, but there remain plenty of caveats.

For one, some observers say a different prostate cancer treatment being developed by Denmark's Bavarian-Nordic has better prospects. Also, there's much debate about the effectiveness of Provenge's method — boosting the body's own immune system to fight cancer. Finally, recent insider trading at Dendreon may have spooked investors.

But make no mistake, approval of Provenge is a watershed event, says Michael Becker, chief executive of biopharmaceutical consulting firm MD Becker Partners. "Despite its detractors, there is something real here," he said.

Dendreon shares skyrocketed 27% on April 29, when it finally won Food and Drug Administration approval for what will be the 18-year-old company's first product, capping a long quest.

Provenge's challenges are that it's complicated and expensive. But it's also revolutionary.

It works by boosting the patient's immune system to recognize cancer as an enemy and fight back. That puts it in the category of a therapeutic vaccine, though the term "vaccine" is misleading.

Provenge neither prevents nor cures prostate cancer. It buys time. Many experts prefer to call it an immunotherapy, and there's much debate in medical circles over whether immunotherapy is the way to go in cancer treatment.

Clinical trials showed that a third of patients on Provenge lived at least three years, compared with 20% on placebo. But the median life extension was just 4.1 months.

Mark Monane, a medical doctor and analyst with Needham & Co., points to three key issues:

Can Dendreon get Provenge to the right patient at the right time? Will doctors and patients have good experiences? And can Dendreon ramp up sales the way it hopes?

He might have added a fourth. Can Dendreon face down looming competition?

Investors have mostly answered yes. The stock is up more than 150% in the past 12 months.

Still, almost unnoticed is that on the day the FDA gave Provenge the nod, the agency also gave fast-track status to Bavarian-Nordic for Prostvac. Fast-tracking gives priority to a drug to accelerate approval. Prostvac has delivered phase-two results that some say look better than results for Provenge.

The three-year survival rate appears to be the same as Provenge, but median survival is 8.5 months.

Important to note, Becker says, is that Prostvac will be off-the-shelf, while Provenge must be custom-tailored to each patient. So it looks as if Prostvac will also be cheaper.

The FDA OK'd Prostvac's fast track because the drug has shown a potential survival benefit and excellent safety record. The target patients are the same as for Provenge — men whose prostate cancer has resisted all other treatments.

The field is getting crowded. This week, BioSante Pharmaceuticals (BPAX) announced that it would revive its development of its GVAX prostate cancer vaccine. The firm had discontinued GVAX in the middle of phase-three trials in 2008. If approved, its vaccine will also be off-the-shelf and not patient-specific.

Dendreon's stock, meanwhile, fell nearly 5% Tuesday on news of heavy insider selling. Monday, key Dendreon executives, including Chief Executive Mitchell Gold, reported to the SEC that they had sold shares on April 29, the day the FDA approved Provenge, and the following day. Gold sold $28 million worth but still holds more than 224,000 shares.

The sales "don't exactly instill confidence in the commercial launch or initial success of the product," Becker said.

Seattle-based Dendreon did not respond to requests for comment.

Whether Dendreon senior executives make money selling their stock is not the big question, Monane says: "The question is, can they execute their plan?"

Monane reckons that the answer is yes. His price target for Dendreon is 62; it now trades near 52. The consensus view of 12 analysts polled by Thomson Reuters is that Dendreon will be profitable by 2012.

The company plans to supply Provenge from plants in New Jersey, Atlanta and Seal Beach, Calif. Three treatments are required, at a combined cost of $93,000. Insurers haven't weighed in yet, but Medicare is covering the treatment.

Cells are taken from patients' blood, then shipped to Dendreon. Provenge, tailored to each patient's chemistry, is added. The fortified solution goes back to the patient for infusion.

Though cumbersome and costly, it's a pioneering approach which proves that boosting the body's own immune system to fight cancer can have benefits. The hope, Monane says, is that Provenge can help fight earlier stages of prostate cancer. Trials are under way.

Becker says Provenge's approval could inspire more investment in cancer vaccine programs. Media coverage has been limited to the good news for prostate patients and for Dendreon, he said, with "little focus on what it means for the rest of the oncology industry and marketplace."

What it means is that, from now on, skeptics should stop pooh-poohing efforts to use the body's own immune system as a weapon against cancer, Becker says.

Monane agrees: "For those people who said there'll never be a cancer vaccine approved — that's so yesterday."

Dendreon出品的抗癌新药获准上市 股价大涨15%

日前，笔者获悉：FDA证实已经批准Dendreon的Provenge (sipuleucel-T)上市申请，这种新药治疗初期前列腺癌男性病人，这些患者利用自体免疫系统对抗疾病。512位病人参与实验，证明了 Provenge具有疗效，能治疗荷尔蒙抗性的前列腺癌患者。

Dendreon一直以来都在挑战传统的放化疗治疗手段，公司希望把肿瘤免疫治疗变成一种简便有效的长期治疗手段。与放疗、化疗和手术治疗不同的是，肿瘤疫苗治疗需要激发身体的免疫系统，长期与肿瘤抗争，疫苗的长期作用可能使致命性的肿瘤疾病变成可控制的“慢性”疾病，让病人的生命得以延长，生活质量得到改善。

Dendreon的Provenge是众多肿瘤免疫新药的先行者，自然更受众人关注。Dendreon公司的共同创办人ChristopherHenney博士很有名气，他先后投资创办了多家生物技术公司，其中最著名的要数Immunex。他在2002年以110亿美元的价格将Immunex卖给了安进公司；2年前，他一手创办的ICOS制药公司也以20亿美元的价格卖给了礼来公司。Dendreon是他创始和投资的另外一家有望腾飞的生物技术企业，作为其大股东，他会不遗余力地促使它走向成功。如果Provenge能够成功获准上市，他也会按照同样的套路把公司卖给大药厂。ChristopherHenney目前还拥有Biomira公司的股份，他最近又同意出任另外一家生物技术公司——CG治疗公司的董事，这两家公司都致力于开发治疗性抗肿瘤疫苗的新药，可见ChristopherHenney这位肿瘤免疫专家对于抗肿瘤免疫制剂是多么情有独钟。