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EU Pharmacovigilance Risk Assessment Committee (PRAC) Minutes of the meeting on 4-7 March 2013
11 April 2013
EMA/248666/2013
Pharmacovigilance Risk Assessment Committee (PRAC)
Product-related pharmacovigilance inspections
5.1.3. Sipuleucel-T
Evaluation of an RMP in the context of an initial Marketing Authorisation Application procedure

WSJ: Novartis said to eye $16B offer for Actavis
May 16, 2013
Actavis ($ACT) has suddenly become the belle of the ball. The Wall Street Journal reports that deal talk is heating up, with Novartis ($NVS) said to be entertaining a $16 billion bid for the generics maker. A $13 billion offer from Valeant ($VRX) and a $15 billion bid from Mylan ($MYL) have both fallen flat.

Analysts have said that, among big drugmakers, Novartis has the most to gain from an Actavis buyout. Aegis Capital's Raghuram Selvaraju told Bloomberg last month that adding Actavis to its portfolio "would mean more to Novartis than anyone else" in terms of meeting its ambitions for its generics business. A Novartis spokesman denied that the company had any interest in an Actavis buyout, however.

Novartis's generics unit, Sandoz, brought in $8.7 billion last year; for comparison's sake, Teva Pharmaceutical Industries' ($TEVA) generic sales last year amounted to $10.4 billion. Actavis, created in last year's merger with Watson Pharmaceuticals, had pro forma 2012 sales of about $8 billion.

Novartis itself says it has "no intention" of pursuing an Actavis deal. So the sources talking about Novartis jumping into the bidding may be mistaken, or Novartis, of course, may be keeping its plans close to the vest. The talk itself was enough to boost Actavis shares to $124.13 this morning.

The flurry of talk around a possible Actavis buyout, whoever the potential

Summer Street's Ling Wang said checks for Provenge winning EU approval were "very high."

One consultant from MCRI told Wang that a positive committee recommendation might happen in the first-quarter 2013, with the Committee for Advanced Therapies (CAT) possibly issuing the opinion.

Currently, Dendreon is evaluating strategic partnerships for Provenge in the EU.

AUA RELEASES FOR TREATING CASTRATION RESISTANT PROSTATE CANCER
Urges providers to incorporate patient treatment goals, preferences and personal goals

SAN DIEGO, CA (May 6, 2013) – Metastatic, castration-resistant prostate cancer (mCRPC) remains an incurable disease, but new treatments –including immunotherapeutic, chemotherapeutic agents, anti-androgens and androgen synthesis inhibitors – may improve outcomes in certain patients, according to a new clinical guideline released today by the American Urological Association (AUA) during its 2013 Annual Meeting in San Diego, CA.

Index Patient 1: Asymptomatic, non-metastatic CRPC
Clinicians should not offer systemic chemotherapy or immunotherapy to patients with non-metastatic CRPC outside the context of a clinical trial.

Index Patient 2: ( PROVENGE RECOMENDED ) Asymptomatic or minimally symptomatic, mCRPC without prior docetaxel chemotherapy

Clinicians should offer abiraterone plus prednisone, docetaxel or sipuleucel-T to patients with asymptomatic or minimally symptomatic mCRPC with good performance status and no prior docetaxel chemotherapy.

Index Patient 3: Symptomatic, mCRPC with good performance status and no prior chemotherapy - No Provenge.

Index Patient 4: Symptomatic, mCRPC with poor performance status and no prior docetaxel chemotherapy
•Clinicians may offer treatment with abiraterone plus prednisone to patients with symptomatic mCRPC with poor performance status and no prior docetaxel chemotherapy.
•Clinicians may offer treatment with ketoconazole plus steroid or radionuclide therapy to patients with symptomatic mCRPC with poor performance status and no prior docetaxel chemotherapy who are unable or unwilling to receive abiraterone plus prednisone.
•Clinicians may offer docetaxel or mitoxantrone chemotherapy to patients with symptomatic mCRPC with poor performance status and no prior docetaxel chemotherapy in select cases, specifically when the performance status is directly related to the cance

FOR IMMEDIATE RELEASE:
May 15, 2013
Contact:
571-483-1365
Fifty years of modern oncology has delivered dramatic progress, offering our patients better treatments, more cures and a better quality of life during and after therapy. We’re also making headway toward preventing cancer from developing in the first place,” said Bruce J. Roth, MD, Chair of ASCO’s Cancer Communications Committee. “Studies being presented at this year’s ASCO Annual Meeting embody a new era of precision medicine, in which we’re taking better aim at vital targets on cancer and immune cells. Several studies also suggest that ‘less is more’ for some cancer treatments, sparing patients unnecessary side-effects and costs.”

Zytiga Phase III Halt Raises Stakes in Prostate Cancer

The next inflection point in prostate cancer is likely to come at the American Society of Clinical Oncology (ASCO) annual meeting, scheduled for June in Chicago, where McLaughlin said Janssen plans to submit the Phase III Zytiga data.

"ASCO will be the key," Biotech Stock Research's Miller said. "I am certain [Janssen] will do another statistical run. If they present non-statistically significant survival data at ASCO, the drug is in real trouble. That's their coming-out party."

Phase 3 trial of Zytiga recently was stopped because the drug achieved stat sig on ONE of two endpoints: progression free survival, of PFS. It failed, however, to achieve stat sig on the second endpoint, overall survival, or OS. Now, with patients crossing over from the placebo cohort and being given Zytiga, the chances that the trial will show stat sig on OS is highly doubtful, throwing into question whether or not Zytiga will be approved by the FDA for pre-chemo applications (where it would compete directly with Provenge.)

Please...do some research and get your facts straight.

Biotech Stocks To Acquire Now For Gains In 2013 ..... We need to correct some errors regarding JNJ's Zytiga.

First, Zytiga is approved by the FDA for patients who have had chemotherapy. Some doctors are prescribing the treatment pre-chemo (i.e., in Provenge's space), but the number is estimated to be only around 20% of the patients eligible for Provenge. Such off-label prescribing of Zytiga is based on an NCCN Category 2B rating for Zytiga based on a small Phase 2 study. The median time of treatment is 8 months, and prednisone must be co-administered with the drug.

Now, what many fail to mention is that when doctors prescribe Zytiga first, they put their patients at risk of having the disease progress during treatment to the point where upon exiting treatment, they are no longer qualified to receive Provenge. Part of the problem is that even after stopping Zytiga at 8 months, say (or whatever), the patient still needs 60 days to 'detox' because of the need to rid his body of prednisone. This is the reason that the Journal of Clinical Oncology made the following recommendation:

"The practical dilemma of the appropriate sequence of use of the two new noncytotoxic agents (sipuleucel-T and abiraterone) is being addressed by trials that are under development. For now, given the broader window of applicability of abiraterone and the longer time required to develop an immune response with sipuleucel-T, if both agents are to be used, it seems reasonable to administer sipuleucel-T first with Abiraterone after additional disease progression. Biomarkers to help define the optimal use of immunotherapy are needed."

600 Million Mkt cap is too low

Provenge cost for safety & effectiveness not for side effects..