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Cempra (CEMP) Gets CRL from FDA for Pneumonia Candidate
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Shares of Cempra, Inc. plunged 57.3% after the company announced that it received a Complete Response Letter (CRL) from the FDA relating to the company’s new drug applications (NDAs) for oral and intravenous formulation of candidate solithromycin.
Cempra’s share price has lost 91.6% so far this year, underperforming the Zacks classified Medical-Drugs industry which has witnessed a decline of 25.3%.
The candidate is being evaluated for the treatment of community-acquired bacterial pneumonia (CABP) in adults. Cempra is currently seeking approval for both intravenous and oral capsule formulations from the FDA and the EMA.
The FDA clarified that it cannot approve the NDAs in their present form and noted that it required additional clinical safety information and resolution of manufacturing facility inspection deficiencies before approving them. During recent inspections of the Wockhardt Limited and Hospira, Inc. manufacturing facilities, the FDA field investigator conveyed deficiencies to representatives of the facilities.
However, the FDA did not request any further information on solithromycin efficacy for CABP in the CRL.
Post review, the FDA determined the risk of hepatotoxicity was not adequately characterized in the NDAs. The FDA noted that the size of the safety database included in the NDA was limited to 920 patients who received solithromycin at the proposed dose and duration. This size was too small to adequately characterize the nature and frequency of serious hepatic adverse effects.
Hence, the FDA has recommended a comparative study to evaluate the safety of solithromycin in patients with CABP. The CRL recommended that Cempra should conduct a study of approximately 9,000 patients who are exposed to solithromycin. This study will enable exclusion of serious drug induced liver injury (DILI) events occurring at a rate of approximately 1:3000 with a 95% probability.
The labeling of the candidate will need to include adequate information about the potential for hepatotoxicity, restricting use to patients who have few therapeutic options and limitations regarding duration of therapy for approval. In addition, a comprehensive plan for post-marketing safety assessment including an enhanced pharmacovigilance program would also be required.
Consequently, Cempra intends to meet the FDA shortly to discuss the issues identified in the CRL, including the design of the recommended clinical safety study and the steps necessary to resolve the deficiencies noted at Wockhardt and Hospira. Cempra also plans to provide the FDA with an update on an alternate GMP manufacturing facility for solithromycin active pharmaceutical ingredient (API), Uquifia.
Cempra is a clinical-stage pharmaceutical company and the CRL was disappointing as solithromycin is one of Cempra’s lead candidate.
The CRL did not come as a surprise as there was an import alert placed on Wockhardt manufacturing facility in Aug 2016. Cempra made a rolling submission of the chemistry, manufacturing, and controls, section of the NDAs beginning in Jan 2016. Cempra began an active dialog with the FDA to determine if the active pharmaceutical ingredient (API), produced at Wockhardt prior to the import alert was adequate for the NDA.
Meanwhile, the company also completed its Marketing Authorization Application (MAA) for solithromycin to the European Medicines Agency (EMA) for the treatment of CABP.
Fusidic acid is Cempra's second candidate. The candidate has completed enrollment in a phase III trial comparing fusidic acid to linezolid in patients with acute bacterial skin and skin structure infections (ABSSSI).
We note that Allergan’s Teflaro is also approved for the treatment of CABP.
Heska’s earnings estimates increased from $1.13 to $1.35 for 2016 and from $1.38 to $1.53 for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 301.64%. Its share price has increased 88.3% year to date.
Vanda’s loss estimates for 2016 narrowed from 62 cents to 45 cents, while its earnings estimates for 2017 decreased from 13 cents to 9 cents over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged almost 72.9% year to date.
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Cempra (CEMP) Gets CRL from FDA for Pneumonia Candidate
Shares of Cempra, Inc. plunged 57.3% after the company announced that it received a Complete Response Letter (CRL) from the FDA relating to the company’s new drug applications (NDAs) for oral and intravenous formulation of candidate solithromycin.
Cempra’s share price has lost 91.6% so far this year, underperforming the Zacks classified Medical-Drugs industry which has witnessed a decline of 25.3%.
The candidate is being evaluated for the treatment of community-acquired bacterial pneumonia (CABP) in adults. Cempra is currently seeking approval for both intravenous and oral capsule formulations from the FDA and the EMA.
The FDA clarified that it cannot approve the NDAs in their present form and noted that it required additional clinical safety information and resolution of manufacturing facility inspection deficiencies before approving them. During recent inspections of the Wockhardt Limited and Hospira, Inc. manufacturing facilities, the FDA field investigator conveyed deficiencies to representatives of the facilities.
However, the FDA did not request any further information on solithromycin efficacy for CABP in the CRL.
Post review, the FDA determined the risk of hepatotoxicity was not adequately characterized in the NDAs. The FDA noted that the size of the safety database included in the NDA was limited to 920 patients who received solithromycin at the proposed dose and duration. This size was too small to adequately characterize the nature and frequency of serious hepatic adverse effects.
Hence, the FDA has recommended a comparative study to evaluate the safety of solithromycin in patients with CABP. The CRL recommended that Cempra should conduct a study of approximately 9,000 patients who are exposed to solithromycin. This study will enable exclusion of serious drug induced liver injury (DILI) events occurring at a rate of approximately 1:3000 with a 95% probability.
The labeling of the candidate will need to include adequate information about the potential for hepatotoxicity, restricting use to patients who have few therapeutic options and limitations regarding duration of therapy for approval. In addition, a comprehensive plan for post-marketing safety assessment including an enhanced pharmacovigilance program would also be required.
Consequently, Cempra intends to meet the FDA shortly to discuss the issues identified in the CRL, including the design of the recommended clinical safety study and the steps necessary to resolve the deficiencies noted at Wockhardt and Hospira. Cempra also plans to provide the FDA with an update on an alternate GMP manufacturing facility for solithromycin active pharmaceutical ingredient (API), Uquifia.
CEMPRA INC Price and Consensus
CEMPRA INC Price and Consensus | CEMPRA INC Quote
Our Take
Cempra is a clinical-stage pharmaceutical company and the CRL was disappointing as solithromycin is one of Cempra’s lead candidate.
The CRL did not come as a surprise as there was an import alert placed on Wockhardt manufacturing facility in Aug 2016. Cempra made a rolling submission of the chemistry, manufacturing, and controls, section of the NDAs beginning in Jan 2016. Cempra began an active dialog with the FDA to determine if the active pharmaceutical ingredient (API), produced at Wockhardt prior to the import alert was adequate for the NDA.
Meanwhile, the company also completed its Marketing Authorization Application (MAA) for solithromycin to the European Medicines Agency (EMA) for the treatment of CABP.
Fusidic acid is Cempra's second candidate. The candidate has completed enrollment in a phase III trial comparing fusidic acid to linezolid in patients with acute bacterial skin and skin structure infections (ABSSSI).
We note that Allergan’s Teflaro is also approved for the treatment of CABP.
Cempra currently carries a Zacks Rank #3 (Hold).
Key Picks in the Sector
A couple of better-ranked stocks in the health care sector include Heska Corp. and Vanda Pharmaceuticals (VNDA - Free Report) . Both of them 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 $1.13 to $1.35 for 2016 and from $1.38 to $1.53 for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 301.64%. Its share price has increased 88.3% year to date.
Vanda’s loss estimates for 2016 narrowed from 62 cents to 45 cents, while its earnings estimates for 2017 decreased from 13 cents to 9 cents over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged almost 72.9% year to date.
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 >>