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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.
On 7/1/09, Repros Therapeutics (NASDAQ:RPRX) announced that an end of Phase 2 meeting is
scheduled with the FDA for late September 2009 to discuss a Phase 3 program investigating the use of
Proellex in the treatment of endometriosis. The Phase 2 study that RPRX completed earlier this year
demonstrated clinically and statistically significant reductions of the three key pain symptoms commonly
experienced by women with endometriosis: dysmenorrhea (painful menses), non-menstrual pelvic pain,
and dyspareunia (painful intercourse).
Additionally, the reduction of pain was accompanied by a statistically significant reduction in the number of
patients requiring pain medication in both doses in this Phase II study compared with placebo. The study
showed no efficacy differences between the 25 mg and 50 mg doses. At the upcoming end of Phase II
meeting, RPRX anticipates obtaining direction from the FDA on the objectives and endpoints the Agency
would like to see used in the pivotal phase 3 efficacy and safety studies in endometriosis. Repros plans to
initiate these studies with doses of 12.5 and 25 mg during 4Q09 and 1Q10, in both the U.S. and Europe.
RPRX expects to file NDAs for the uterine fibroids indications in the second half of 2010.
On 7/1/09, Acorda Therapeutics (NASDAQ:ACOR) announced an exclusive deal with Biogen Idec
(NASDAQ:BIIB) to develop and commercialize Fampridine-SR in markets outside the U.S. while Acorda will
continue to develop and commercialize Fampridine-SR in the U.S. Acorda will receive an upfront payment
of $110 million and additional payments of up to $400 million based on the successful achievement of
future regulatory and sales milestones along with tiered, double-digit royalty payments on ex-US sales.
The FDA is currently reviewing a New Drug Application (NDA) for Fampridine-SR with a Priority Review (six-
month) designation and a PDUFA action date of 10/22/09 for a possible FDA decision.
On 4/23/09, ACOR announced the resubmission of its NDA for Fampridine-SR to the FDA as a new
therapy being developed to improve walking ability in people with multiple sclerosis (MS). Acorda received
a Refuse to File (RTF) letter for the Fampridine-SR NDA on 3/30/09, which cited the need to correct
formatting issues with the application and requested additional supporting information before the NDA
could be accepted for review. On 5/6/09, the FDA accepted the NDA with a priority review designation and
PDUFA decision date of 10/22/09 as there are currently no FDA approved treatments to improve the
walking ability of people with MS.
On 7/1/09, Discovery Labs (NASDAQ:DSCO) provided an update following the receipt of written minutes
from its 6/2/09 meeting with the FDA which followed the Agency's 4/17/09 Complete Response Letter
(CRL) for Surfaxin (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature.
At this meeting, DSCO learned that the FDA will now apply a newly-defined standard to determine whether
the Company has adequately demonstrated comparability of Surfaxin clinical to commercial drug product.
DSCO stated that this new standard represents a significant hurdle for the approval of Surfaxin.
Considering the Agency’s newly-defined standard, DSCO now believes that it is unlikely to satisfy this
requirement with existing preclinical comparability data and gain Surfaxin approval in the near term.
DSCO stated that the central remaining issue relates to whether data generated using the BAT and
preterm lamb model of RDS supports the comparability of Surfaxin clinical to commercial drug product to
the FDA's satisfaction. This comparability issue is limited to this NDA for Surfaxin and does not alter the
Company’s existing clinical programs or development plans for its pipeline. DSCO will now focus on
maximizing the inherent value of its novel KL4 surfactant and aerosolization platforms and will minimize
development risk by leveraging Surfaxin's established proof-of-efficacy in RDS.
The two highest priority pipeline programs are Surfaxin LS and Aerosurf and the Company stated that the
synthetic nature and formulation flexibility of Discovery Labs' KL4 surfactant platform also supports
expansion into a wide range of respiratory disease conditions. DSCO intends to pursue these
opportunities through strategic alliances, although there can be no assurance that such alliances can be
obtained.
On 6/11/09, Human Genome Sciences (NASDAQ: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. On 7/1/09, HGSI announced that it expects to have top-line results
available on 7/20/09 for BLISS-52, the first of two pivotal Phase 3 clinical trials of BENLYSTA in systemic
lupus erythematosus (SLE). HGSI will host a conference call to discuss the results on 7/20/09 at 8:15 AM
Eastern.
On 7/1/09, Pharming Group (AMS:PHARM) (PINK:PHGUF) announced that it is on track to re-file a request
for European Union (EU) marketing approval for its lead product, Rhucin, in September 2009 as the
Company confirmed positive results from a final clinical study that included 70 patients in Europe and
North America. According to Pharming, none of the Rhucin treated patients experienced a relapse of
symptoms in the same attack and there were no clinically relevant safety concerns for the drug. The
European Medicines Agency (EMEA) has twice rejected the Company's application to market Rhucin,
which treats hereditary angioedema (HAE), which is a condition that causes acute attacks of painful
swelling of the skin, intestine, mouth, and throat. Pharming expects to submit its EU marketing
authorization application for Rhucin in September 2009 with a FDA filing expected to follow.
Disclosure: No positions.
Original Article
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.
On 7/1/09, Repros Therapeutics (NASDAQ:RPRX) announced that an end of Phase 2 meeting is
scheduled with the FDA for late September 2009 to discuss a Phase 3 program investigating the use of
Proellex in the treatment of endometriosis. The Phase 2 study that RPRX completed earlier this year
demonstrated clinically and statistically significant reductions of the three key pain symptoms commonly
experienced by women with endometriosis: dysmenorrhea (painful menses), non-menstrual pelvic pain,
and dyspareunia (painful intercourse).
Additionally, the reduction of pain was accompanied by a statistically significant reduction in the number of
patients requiring pain medication in both doses in this Phase II study compared with placebo. The study
showed no efficacy differences between the 25 mg and 50 mg doses. At the upcoming end of Phase II
meeting, RPRX anticipates obtaining direction from the FDA on the objectives and endpoints the Agency
would like to see used in the pivotal phase 3 efficacy and safety studies in endometriosis. Repros plans to
initiate these studies with doses of 12.5 and 25 mg during 4Q09 and 1Q10, in both the U.S. and Europe.
RPRX expects to file NDAs for the uterine fibroids indications in the second half of 2010.
On 7/1/09, Acorda Therapeutics (NASDAQ:ACOR) announced an exclusive deal with Biogen Idec
(NASDAQ:BIIB) to develop and commercialize Fampridine-SR in markets outside the U.S. while Acorda will
continue to develop and commercialize Fampridine-SR in the U.S. Acorda will receive an upfront payment
of $110 million and additional payments of up to $400 million based on the successful achievement of
future regulatory and sales milestones along with tiered, double-digit royalty payments on ex-US sales.
The FDA is currently reviewing a New Drug Application (NDA) for Fampridine-SR with a Priority Review (six-
month) designation and a PDUFA action date of 10/22/09 for a possible FDA decision.
On 4/23/09, ACOR announced the resubmission of its NDA for Fampridine-SR to the FDA as a new
therapy being developed to improve walking ability in people with multiple sclerosis (MS). Acorda received
a Refuse to File (RTF) letter for the Fampridine-SR NDA on 3/30/09, which cited the need to correct
formatting issues with the application and requested additional supporting information before the NDA
could be accepted for review. On 5/6/09, the FDA accepted the NDA with a priority review designation and
PDUFA decision date of 10/22/09 as there are currently no FDA approved treatments to improve the
walking ability of people with MS.
On 7/1/09, Discovery Labs (NASDAQ:DSCO) provided an update following the receipt of written minutes
from its 6/2/09 meeting with the FDA which followed the Agency's 4/17/09 Complete Response Letter
(CRL) for Surfaxin (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature.
At this meeting, DSCO learned that the FDA will now apply a newly-defined standard to determine whether
the Company has adequately demonstrated comparability of Surfaxin clinical to commercial drug product.
DSCO stated that this new standard represents a significant hurdle for the approval of Surfaxin.
Considering the Agency’s newly-defined standard, DSCO now believes that it is unlikely to satisfy this
requirement with existing preclinical comparability data and gain Surfaxin approval in the near term.
DSCO stated that the central remaining issue relates to whether data generated using the BAT and
preterm lamb model of RDS supports the comparability of Surfaxin clinical to commercial drug product to
the FDA's satisfaction. This comparability issue is limited to this NDA for Surfaxin and does not alter the
Company’s existing clinical programs or development plans for its pipeline. DSCO will now focus on
maximizing the inherent value of its novel KL4 surfactant and aerosolization platforms and will minimize
development risk by leveraging Surfaxin's established proof-of-efficacy in RDS.
The two highest priority pipeline programs are Surfaxin LS and Aerosurf and the Company stated that the
synthetic nature and formulation flexibility of Discovery Labs' KL4 surfactant platform also supports
expansion into a wide range of respiratory disease conditions. DSCO intends to pursue these
opportunities through strategic alliances, although there can be no assurance that such alliances can be
obtained.
On 6/11/09, Human Genome Sciences (NASDAQ: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. On 7/1/09, HGSI announced that it expects to have top-line results
available on 7/20/09 for BLISS-52, the first of two pivotal Phase 3 clinical trials of BENLYSTA in systemic
lupus erythematosus (SLE). HGSI will host a conference call to discuss the results on 7/20/09 at 8:15 AM
Eastern.
On 7/1/09, Pharming Group (AMS:PHARM) (PINK:PHGUF) announced that it is on track to re-file a request
for European Union (EU) marketing approval for its lead product, Rhucin, in September 2009 as the
Company confirmed positive results from a final clinical study that included 70 patients in Europe and
North America. According to Pharming, none of the Rhucin treated patients experienced a relapse of
symptoms in the same attack and there were no clinically relevant safety concerns for the drug. The
European Medicines Agency (EMEA) has twice rejected the Company's application to market Rhucin,
which treats hereditary angioedema (HAE), which is a condition that causes acute attacks of painful
swelling of the skin, intestine, mouth, and throat. Pharming expects to submit its EU marketing
authorization application for Rhucin in September 2009 with a FDA filing expected to follow.
Disclosure: No positions.
Original Article
| FDA Trades: Repros Therapeutics, Acorda Therapeutics, and more by BioMedReports.com, July 2, 2009 |
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
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
| BioMedReports.com is an informational website that focuses on healthcare and biomedical stocks. BioMedReport's Bio Visit the website at BioMedReports,com. |
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