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IPCI

Intellipharmaceutics

$2.38

0.139 (6.20%)

, AZN

AstraZeneca

$32.29

0.03 (0.09%)

18:37
10/07/16
10/07
18:37
10/07/16
18:37

Intellipharmaceutics announces tentative FDA approval for generic Seroquel XR

Intellipharmaceutics (IPCI) announced that the Company received tentative approval from the U.S. FDA for the Company's abbreviated new drug application for quetiapine fumarate extended-release tablets in the 50, 150, 200, 300 and 400 mg strengths. The Company's tentatively-approved product is a generic equivalent for the corresponding strengths of the branded product Seroquel XR sold in the United States by Astra Zeneca (AZN). Pursuant to a settlement agreement between the Company and AstraZeneca dated July 30, 2012, the Company is permitted to launch its generic versions of the 50, 150, 200, 300 and 400 mg strengths of generic Seroquel XR, on November 1, 2016, subject to FDA final approval of the Company's ANDA for those strengths. Such FDA final approval is subject to a 180 day exclusivity period relating to a prior filer or filers of a generic equivalent of the branded product. To our knowledge, two companies have first-to-file status and may be in a position to launch on November 1, 2016, although we cannot be certain of that date. Our intent is to launch these strengths after FDA final approval following expiry of the other companies' exclusivity period(s). There are currently no generics of Seroquel XR available in the U.S. market as the product is still under Astra Zeneca's patent protection until November 1, 2017. There can be no assurance that the Company's quetiapine fumarate extended-release tablets in any of the 50, 150, 200, 300 and 400 mg strengths will receive final FDA approval, or if approved, that they will be successfully commercialized.

IPCI

Intellipharmaceutics

$2.38

0.139 (6.20%)

AZN

AstraZeneca

$32.29

0.03 (0.09%)

  • 07

    Oct

  • 20

    Oct

  • 16

    Nov

IPCI Intellipharmaceutics
$2.38

0.139 (6.20%)

10/04/16
BMUR
10/04/16
INITIATION
Target $8
BMUR
Buy
Intellipharmaceutics assumed with a Buy at Brean Capital
Brean Capital analyst Difei Yang assumed coverage of Intellipharmaceutics with a Buy rating and $8 price target.
AZN AstraZeneca
$32.29

0.03 (0.09%)

09/13/16
EXAN
09/13/16
DOWNGRADE
EXAN
Neutral
AstraZeneca downgraded to Neutral from Outperform at Exane BNP Paribas
09/23/16
PIPR
09/23/16
INITIATION
PIPR
Overweight
AstraZeneca initiated with an Overweight at Piper Jaffray
Piper Jaffray analyst Richard Purkiss started AstraZeneca with an Overweight rating and GBP 60 price target.
09/23/16
09/23/16
INITIATION

On The Fly: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Morgan Stanley analyst Brian Nowak initiated Activision Blizzard (ATVI) and Electronic Arts (EA), both with Overweight ratings. The analyst is bullish on the digital gaming shift away from "units sold" to a business model based on users, engagement, and digital monetization. He sees digital in-game offerings resulting in recurring and growth user bases, increased per-game engagement, and further monetization opportunities. 2. AstraZeneca (AZN) and GlaxoSmithKline (GSK) both initiated with Overweight ratings by Piper Jaffray analyst Richard Purkiss. 3. Achillion (ACHN) initiated with an Outperform by Wedbush analyst Heather Behanna, who set a $13 price target on the shares. 4. Sysco (SYY) initiated with an Underweight at Barclays and $48 price target by analyst Karen Short. 5. Five Below (FIVE), Dollar Tree (DLTR) and Dollar General (DG) all initiated with Equal Weight ratings by Barclays analyst Karen Short. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
10/07/16
PIPR
10/07/16
NO CHANGE
PIPR
Neutral
Piper still sees Clovis' rucaparib getting broader indication than Lynparza
Piper Jaffray analyst Steven Breazzano said the rucaparib response rates in platinum resistant and platinum refractory patients of 25% and 0%, respectively, reported by Clovis Oncology (CLVS) are lower than some may have been expecting and "seemingly negative on the surface." However, he continues to believe rucaparib will be approved in BRCA patients who have received 2+ lines of therapy, which is an earlier and broader patient population than assigned to competitor AstraZeneca's (AZN) Lynparza, he tells investors. The ultimate market potential and key to success is the maintenance setting, for which TESARO's (TSRO) niraparib is still best-positioned, adds Breazzano, who keeps a Neutral rating on Clovis shares.

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