FDA Calendar Updates: BDSI, SVNT Deadlines Approach

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.

Before reviewing the latest updates, below are two companies from the FDA Calendar with pending catalysts expected within the next week.

Savient Pharma (NASDAQ:SVNT) announced on 5/7/09 that its pending BLA for Krystexxa (pegloticase), a novel biological drug for treatment failure gout patients, will be reviewed by an Arthritis Advisory Committee appointed by the FDA on 6/16/09. In December, the FDA accepted the Company's BLA and granted priority review status, but SVNT submitted several key amendments for the BLA earlier this year in January. The FDA accepted the amendments and determined that the additional information constituted a major amendment and extended the original PDUFA action date by three months to 8/1/09.

BioDelivery Sciences (NASDAQ:BDSI) has a pending Onsolis (BEMA fentanyl) NDA resubmission for the proposed treatment of breakthrough cancer pain through a small, dissolving polymer delivery system for the opiate painkiller fentanyl designed for quick absorption through the cheek. On 12/15/08, BDSI announced in a press release that the FDA requested conversion of the originally submitted risk minimization action plan (RiskMAP) to a Risk Evaluation and Mitigation Strategy (REMS) and informed the Company that all other aspects of the NDA review were complete.

Given this information, the prospects for Onsolis approval appear excellent, with an approval decision possible as early as Friday 6/12/09 or the following Monday based on a Class II (six-month) review by the agency on the resubmission of the required REMS by BDSI. In the same press release, BDSI provided guidance for expected approval of the Onsolis approval during the first half of 2009.

Earlier this year, BDSI raised $6M in cash from partner Meda AB [STO:MEDAA] ($2.3B U.S. Dollar market cap) from a $3M expanded marketing agreement (which includes all countries except Taiwan and South Korea) and a $3M advance of the $30M milestone payment triggered by FDA approval. The remaining $27M cash milestone payment on FDA approval for Onsolis represents about 22% of the Company's current market cap of $123M, in addition to double-digit royalties that will be received on product sales, an additional $30M possible in sales-related milestone payments, and a $5M milestone payment that is due upon EU approval/launch.

While I do not typically hold small and micro-cap bio-med stocks through binary events such as FDA decisions and clinical trial results, BDSI is an exception for me and the Company expects to generate positive operating cash flow this year if Onsolis is approved. Also, the Company is debt free with a promising mid-stage pipeline based on its drug delivery technology platform that can be funded through milestone payments and royalties from Meda AB (which expects peak sales exceeding $200M for Onsolis).

Osteotech (NASDAQ:OSTE): On 6/10/09, OSTE announced that it has completed enrollment for the clinical trial of its DuraTech BioRegeneration Matrix. Based upon Osteotech's proprietary HCT (human collagen technology) platform, DuraTech is used to repair dura mater (the tough, outermost membrane surrounding the brain and spinal cord) during cranial surgical procedures.

A total of 60 patients were enrolled in the clinical study and the trial will evaluate the patients at 30 and 90 days post-operatively to assess the safety of DuraTech compared to historical surgical procedure outcomes. Osteotech plans to utilize the results from this trial to support its 510(k) filing for marketing clearance with the FDA during 3Q09 with expected marketing clearance before year-end.

Human Genome Sciences (NASDAQ:HGSI): On 6/11/09, HGSI announced Phase 2 continuation data which demonstrated sustained improvement in disease activity and patient response rate through four years of BENLYSTA therapy in combination with standard of care in patients with serologically active systemic lupus erythematosus (SLE). The frequency of disease flares as measured by the SELENA SLEDAI flare index and by BILAG A or B organ domain scores decreased over four years of BENLYSTA therapy and there was no increase in overall adverse events, serious adverse events, malignancies or serious infections over time.

HGSI and GlaxoSmithKline (NYSE:GSK) have selected BENLYSTA as the brand name for belimumab (formerly known as LymphoStat-B). HGS and GSK expect to report the first Phase 3 data for BENLYSTA in July 2009 from the BLISS-52 trial, with results from BLISS-76 anticipated in November 2009. BLISS-52 and BLISS-76 are the largest clinical trials ever conducted in lupus patients. BENLYSTA is being developed by HGSI and GSK under a co-development and commercialization agreement entered into in August 2006.

Transcept Pharma (NASDAQ:TSPT): On 6/11/09, TSPT announced that the FDA has informed the Company that it should expect to receive formal notice of a three month extension of the review period for the new drug application (NDA) for Intermezzo (zolpidem tartrate sublingual tablet). The Intermezzo NDA had been assigned a PDUFA action date of 7/30/09.

Under this revised timeline, TSPT now anticipates action from the FDA on the NDA on or before 10/31/09. In the normal course of the Intermezzo NDA review, the FDA previously requested additional information regarding middle of the night dosing instructions. As both the request and the TSPT response occurred late in the review cycle, the FDA has informed the company that it will extend the NDA review cycle by three months to consider the new information.

Disclosure: Long BDSI

Comments

[paultheprofit:]

yet insider's JUST sold BDSI..Hmmm..

2009-06-05-
-2009-06-08
Sale 2009-06-09
5:26 pm BIODELIVERY SCIENCES INTERNATIONAL INC BDSI Finn Andrew L
(Executive Vice President) 25,000 $6.75 $168,750 752,413
(Direct) View
2009-06-05
Sale 2009-06-09
5:25 pm BIODELIVERY SCIENCES INTERNATIONAL INC BDSI Sirgo Mark A
(President and CEO
Director) 30,000 $6.667 $200,000 808,175
(Direct) View
2009-06-05
Sale 2009-06-09
5:25 pm BIODELIVERY SCIENCES INTERNATIONAL INC BDSI MCNULTY JAMES A
(Chief Financial Officer) 20,000 $6.5 $130,000 39,371
(Direct) View
2009-06-03-
-2009-06-04
Sale 2009-06-05
5:19 pm BIODELIVERY SCIENCES INTERNATIONAL INC BDSI Sirgo Mark A
(President and CEO
Director) 20,000 $6.009 $120,182 838,175
(Direct) View
2009-06-03-
-2009-06-04
Sale 2009-06-05
5:19 pm BIODELIVERY SCIENCES INTERNATIONAL INC BDSI MCNULTY JAMES A
(Chief Financial Officer) 20,000 $6.009 $120,182 59,371
(Direct) View
2009-06-03-
-2009-06-04
Sale 2009-06-05
5:19 pm BIODELIVERY SCIENCES INTERNATIONAL INC BDSI Finn Andrew L
(Executive Vice President) 25,000 $6.009 $150,227 777,413
(Direct)

Jun 12 08:26 AM

[nosajio:]

If Yahoo is correct, those are only automatic sales and don't tell us anything.

Jun 12 10:29 AM

[kvapausa:]

Insiders hold circa 50% of company, so they just choose sold small portion of their holdings, just in case. Smart move !!!

Jun 13 01:44 AM

[Mike Havrilla:]

Approval on the way for BDSI's Onsolis:

RALEIGH, N.C., Jun 15, 2009 (BUSINESS WIRE) -- --FDA Action Forthcoming BioDelivery Sciences International, Inc. (BDSI) today announced that the company has reached agreement with the U.S. Food and Drug Administration's (FDA) Division of Anesthesia, Analgesia and Rheumatology Products and a multidisciplinary review team on all aspects of the company's New Drug Application (NDA) for ONSOLIS(TM) (fentanyl buccal soluble film), including the Risk Evaluation and Mitigation Strategy (REMS). Although the FDA did not meet its action date of last Friday for this NDA, the Division has informed the company that FDA will not be issuing a review extension letter as their action on the NDA is forthcoming. BDSI received a Complete Response letter from FDA on the NDA for ONSOLIS on August 28, 2008, with the only deficiency being the new requirement for a REMS. The REMS was not required at the time the NDA was originally submitted to FDA in October 2007. The REMS was formally submitted to the FDA on December 12, 2008 and the submission was placed under a six month review period. "FDA informed us on Friday that given how close they are to taking their action, they saw no need for issuing a review extension letter, which would have formally given them more time to complete their review. In other words, they simply need a little more time, which we believe is not inconsistent with other recent NDA approvals for other products at the Agency where a REMS was required for approval," stated Dr. Mark A. Sirgo, President and CEO of BioDelivery Sciences. "We view this as positive news, together with the fact that we have reached agreement with the reviewing division and the review team on all aspects of our NDA, including our REMS. Our dialog and working relationship with the reviewing division have been outstanding and have been fundamental to the progress we have made in working with them in this significant undertaking, to complete the first 'opioid' REMS and the first REMS for this Division. We look forward to FDA's forthcoming action," stated Dr. Sirgo. "Although we can not pinpoint the exact timing of when the FDA's action might occur, we have previously indicated that we expect a first half 2009 approval of the NDA for ONSOLIS. Based on our discussion with FDA last Friday, we should be within a few weeks of that target." Dr. Sirgo continued, "As it relates to BDSI's current financial position, we are pleased to announce that over the last several weeks we have received funds from the exercise of certain outstanding warrants. The receipt of these funds alone should allow us to comfortably manage the company into the fourth quarter of this year, including the continued advancement of our pipeline, without any additional financing required."


On Jun 12 08:26 AM paultheprofit wrote:

> yet insider's JUST sold BDSI..Hmmm..
>
> 2009-06-05-
> -2009-06-08
> Sale 2009-06-09
> 5:26 pm BIODELIVERY SCIENCES INTERNATIONAL INC BDSI Finn Andrew L
>
> (Executive Vice President) 25,000 $6.75 $168,750 752,413
> (Direct) View
> 2009-06-05
> Sale 2009-06-09
> 5:25 pm BIODELIVERY SCIENCES INTERNATIONAL INC BDSI Sirgo Mark A
>
> (President and CEO
> Director) 30,000 $6.667 $200,000 808,175
> (Direct) View
> 2009-06-05
> Sale 2009-06-09
> 5:25 pm BIODELIVERY SCIENCES INTERNATIONAL INC BDSI MCNULTY JAMES
> A
> (Chief Financial Officer) 20,000 $6.5 $130,000 39,371
> (Direct) View
> 2009-06-03-
> -2009-06-04
> Sale 2009-06-05
> 5:19 pm BIODELIVERY SCIENCES INTERNATIONAL INC BDSI Sirgo Mark A
>
> (President and CEO
> Director) 20,000 $6.009 $120,182 838,175
> (Direct) View
> 2009-06-03-
> -2009-06-04
> Sale 2009-06-05
> 5:19 pm BIODELIVERY SCIENCES INTERNATIONAL INC BDSI MCNULTY JAMES
> A
> (Chief Financial Officer) 20,000 $6.009 $120,182 59,371
> (Direct) View
> 2009-06-03-
> -2009-06-04
> Sale 2009-06-05
> 5:19 pm BIODELIVERY SCIENCES INTERNATIONAL INC BDSI Finn Andrew L
>
> (Executive Vice President) 25,000 $6.009 $150,227 777,413
> (Direct)

Jun 15 08:31 AM

[momentum74:]

Mike Harvilla what do you think about BIEL.PK they are applying for FDA CC call on thursday. They are up huge today.


On Jun 15 08:31 AM Mike Havrilla wrote:

> Approval on the way for BDSI's Onsolis:
>
> RALEIGH, N.C., Jun 15, 2009 (BUSINESS WIRE) -- --FDA Action Forthcoming
> BioDelivery Sciences International, Inc. (seekingalpha.com/symbo...)
> today announced that the company has reached agreement with the U.S.
> Food and Drug Administration's (seekingalpha.com/symbo...)
> Division of Anesthesia, Analgesia and Rheumatology Products and a
> multidisciplinary review team on all aspects of the company's New
> Drug Application (seekingalpha.com/symbo...) for ONSOLIS(seekingalpha.com/symbo...)
> (fentanyl buccal soluble film), including the Risk Evaluation and
> Mitigation Strategy (seekingalpha.com/symbo...). Although
> the FDA did not meet its action date of last Friday for this NDA,
> the Division has informed the company that FDA will not be issuing
> a review extension letter as their action on the NDA is forthcoming.
> BDSI received a Complete Response letter from FDA on the NDA for
> ONSOLIS on August 28, 2008, with the only deficiency being the new
> requirement for a REMS. The REMS was not required at the time the
> NDA was originally submitted to FDA in October 2007. The REMS was
> formally submitted to the FDA on December 12, 2008 and the submission
> was placed under a six month review period. "FDA informed us on Friday
> that given how close they are to taking their action, they saw no
> need for issuing a review extension letter, which would have formally
> given them more time to complete their review. In other words, they
> simply need a little more time, which we believe is not inconsistent
> with other recent NDA approvals for other products at the Agency
> where a REMS was required for approval," stated Dr. Mark A. Sirgo,
> President and CEO of BioDelivery Sciences. "We view this as positive
> news, together with the fact that we have reached agreement with
> the reviewing division and the review team on all aspects of our
> NDA, including our REMS. Our dialog and working relationship with
> the reviewing division have been outstanding and have been fundamental
> to the progress we have made in working with them in this significant
> undertaking, to complete the first 'opioid' REMS and the first REMS
> for this Division. We look forward to FDA's forthcoming action,"
> stated Dr. Sirgo. "Although we can not pinpoint the exact timing
> of when the FDA's action might occur, we have previously indicated
> that we expect a first half 2009 approval of the NDA for ONSOLIS.
> Based on our discussion with FDA last Friday, we should be within
> a few weeks of that target." Dr. Sirgo continued, "As it relates
> to BDSI's current financial position, we are pleased to announce
> that over the last several weeks we have received funds from the
> exercise of certain outstanding warrants. The receipt of these funds
> alone should allow us to comfortably manage the company into the
> fourth quarter of this year, including the continued advancement
> of our pipeline, without any additional financing required."

Jun 15 11:17 PM

[momentum74:]

Mike what do you think about BIEL.PK. Stock was on fire today when they annouced they are filing with the FDA. Looks undervalued but I wanted to know what you think?

Jun 15 11:20 PM