We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Celgene (CELG) Gets Paragraph IV Notice Letter for Pomalyst
Read MoreHide Full Article
Celgene Corporation recently received a Paragraph IV Notice Letter advising that Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) submitted an Abbreviated New Drug Application (ANDA) to the FDA seeking an approval to manufacture and market a generic version of Pomalyst (pomalidomide) 1 mg, 2 mg, 3 mg and 4 mg in the U.S.
Celgene outperformed the Zacks classified Medical-Biomedical and Genetics industry in the past one year. The stock gained 16.4% during this period, compared with a decline of 12.3% for the industry.
The letter contains Paragraph IV certifications against certain patents related to Pomalyst. Celgene is currently assessing the notice.
As per the information provided on the FDA’s site, a company can seek approval from FDA to market a generic drug before the expiration of a patent relating to the brand name drug upon which the generic is based. The generic applicant must certify in its ANDA whether the patent in question is invalid or is not infringed by the generic product which is known as "paragraph IV certification." Secondly, the applicant must notify the patent holder of the submission of the ANDA
We note that Pomalyst is already approved in the U.S. for the indication of multiple myeloma, in combination with dexamethasone for patients who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
The drug is already approved under the trade name Imnovid in the European Union for relapsed and refractory multiple myeloma, in combination with dexamethasone, for adult patients who have received at least two prior therapies including both lenalidomide and bortezomib and have demonstrated disease progression on the last therapy.
The drug’s sale was $1.3 billion in 2016, up from $983.3 million in 2015. Pomalyst is a key drug for Celgene and hence we expect the company to file an infringement suit against Teva within 45 days of the ANDA notification. This in turn, will automatically defer the FDA’s approval to market the generic version postponed for 30 months, unless, before that time, the patent expires or is judged to be invalid or not infringed.
Heska’s earnings estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018 over the last 30 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 291.54%.
Retrophin’s loss estimates narrowed from 85 cents to 72 cents for 2017 and from 67 cents to 53 cents for 2018 over the last 30 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 80.55%.
Zacks’ Best Private Investment Ideas
In addition to the recommendations that are available to the public on our website, how would you like to follow all Zacks' private buys and sells in real time?
Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Starting today, for the next month, you can have unrestricted access. Click here for Zacks' private trades >>
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Celgene (CELG) Gets Paragraph IV Notice Letter for Pomalyst
Celgene Corporation recently received a Paragraph IV Notice Letter advising that Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) submitted an Abbreviated New Drug Application (ANDA) to the FDA seeking an approval to manufacture and market a generic version of Pomalyst (pomalidomide) 1 mg, 2 mg, 3 mg and 4 mg in the U.S.
Celgene outperformed the Zacks classified Medical-Biomedical and Genetics industry in the past one year. The stock gained 16.4% during this period, compared with a decline of 12.3% for the industry.
The letter contains Paragraph IV certifications against certain patents related to Pomalyst. Celgene is currently assessing the notice.
As per the information provided on the FDA’s site, a company can seek approval from FDA to market a generic drug before the expiration of a patent relating to the brand name drug upon which the generic is based. The generic applicant must certify in its ANDA whether the patent in question is invalid or is not infringed by the generic product which is known as "paragraph IV certification." Secondly, the applicant must notify the patent holder of the submission of the ANDA
We note that Pomalyst is already approved in the U.S. for the indication of multiple myeloma, in combination with dexamethasone for patients who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
The drug is already approved under the trade name Imnovid in the European Union for relapsed and refractory multiple myeloma, in combination with dexamethasone, for adult patients who have received at least two prior therapies including both lenalidomide and bortezomib and have demonstrated disease progression on the last therapy.
The drug’s sale was $1.3 billion in 2016, up from $983.3 million in 2015. Pomalyst is a key drug for Celgene and hence we expect the company to file an infringement suit against Teva within 45 days of the ANDA notification. This in turn, will automatically defer the FDA’s approval to market the generic version postponed for 30 months, unless, before that time, the patent expires or is judged to be invalid or not infringed.
Zacks Rank & Key Picks
Celgene currently carries a Zacks Rank #3 (Hold).
Some other better-ranked stocks in the health care sector include Heska Corp. and Retrophin, Inc. . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018 over the last 30 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 291.54%.
Retrophin’s loss estimates narrowed from 85 cents to 72 cents for 2017 and from 67 cents to 53 cents for 2018 over the last 30 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 80.55%.
Zacks’ Best Private Investment Ideas
In addition to the recommendations that are available to the public on our website, how would you like to follow all Zacks' private buys and sells in real time?
Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Starting today, for the next month, you can have unrestricted access. Click here for Zacks' private trades >>