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In investing, there are few events that can have as dramatic impact on a stock price as an FDA decision on an early or development stage drug company. In this report, we highlight four companies who have PDUFA dates scheduled between now and the end of June which should results in large reactions in the stocks depending on the FDA’s decision. Chiasma, KemPharm, Lipocine, and Vanda Pharmaceuticals each have interesting products that could soon be introduced to the U.S. market.
Chiasma, Inc. (NASDAQ – CHMA)
Chiasma Inc. is a late-stage biopharmaceutical company focused on improving the lives of patients suffering from orphan disease by developing and commercializing novel oral forms of therapies that are currently available by injection only.
The company intends to accomplish this through the use of their proprietary Transient Permeability Enhancer (TPE) technology platform. The company’s lead product candidate, oral octreotide, is a novel formulation of octreotide designated to treat acromegaly, a condition that results from the body’s production of excess growth hormone which leads to excess growth of certain parts of the body. In August 2015, the U.S. FDA accepted a New Drug Application (NDA) from Chiasma for review for the maintenance therapy of adult patients with acromegaly. The company has a target Prescription Drug User Fee Act (PDUFA) date of April 15, 2016, where the company could learn whether their Octreotide Capsules are approved for use in the U.S.
The company has completed the Phase III trial in the U.S. for the use of octreotide capsules for the treatment of Acromegaly and has the Phase III trial underway in the E.U.
April 1-4, 2016, the company participated at ENDO 2016 in Boston, MA. ENDO is the largest and most well-attended event in the field of endocrinology. There were two presentations at the conference related to Chiasma’s Oral Octreotide product.
On March 14, 2016, the company initiated the Phase III Trial to support the E.U. registration of the Oral Octreotide Capsules for the treatment of Acromegaly.
Also on March 14, 2016, Chiasma reported Q4 2015 operating results. The company didn’t have revenues to report as they await a decision from the FDA on their first potentially commercial product.
Chiasma is awaiting the FDA’s imminent decision on its use of octreotide capsules for the treatment of Acromegaly. The Phase III trial showed 65% of patients who received octreotide capsules twice-a-day achieved disease control as measured by circulating concentrations of insulin-like growth factor-1 and growth hormone concentrations at 7 months (core treatment period), meeting the primary endpoint and achieved disease control at 13 months (end of treatment). It appears that this data would be viewed positively by the FDA as this is a challenging disease that is currently treated with chronic injections.
KemPharm, Inc. (NASDAQ – KMPH)
KemPharm, Inc. is a clinical-stage pharmaceutical company engaged in the discovery and development of new proprietary prodrugs. The company’s advanced product candidate is KP201/APAP, which consists of KP201, its new molecular entity (NME) prodrug of hydrocodone, formulated in combination with acetaminophen. The company is developing KP201/APAP as an immediate release product candidate for the treatment of acute to moderately severe pain and has designed KP201/APAP with abuse-deterrent properties to address the epidemic of opioid abuse in the U.S. KemPharm is also involved in building a pipeline of additional NME prodrug product candidates that target market opportunities in pain, ADHD, and other central nervous system indications.
Product Candidate Status Next Milestone
KP201/APAP Clinical PDUFA – June 9, 2016
KP201/IR (APAP-free) Clinical IND Submission – 2016
KP511/ER Clinical Human POC Data – 2016
KP606/IR Preclinical Human POC Data – 2017
KP606/ER Preclinical Preclinical Development
KP746 Preclinical Preclinical Development
KP415 Preclinical Human POC Data – 2016
KP303 Preclinical Preclinical Development
On April 12, 2016, the company will present at 10:40 am at the Needham & Company’s 15th Annual Healthcare Conference. The presentation will be webcast at http://investors.kempharm.com.
March 28, 2016, KemPharm received clearance from the FDA to initiate human clinical trials of KP511, the prodrug of hydromorphone. The drug is being developed as an abuse-deterrent, extended-release prodrug for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.
The company received an NDA user fee waiver from the FDA on March 24, 2016. The waiver is granted to small businesses for the first human trial submitted to the FDA for review and was in the amount of $2.4 million.
The company’s technology is targeted at solving the huge problem of opioid addiction and abuse. With the expected PDUFA decision by June 9, 2016, we would look for the stock to respond favorably to a positive outcome.
Lipocine Inc. (NASDAQ – LPCN)
Lipocine Inc. is a specialty pharmaceutical company which develops pharmaceutical products using its oral drug delivery technology in the area of mens and womens health. The company offers a portfolio of proprietary product candidates designed to produce pharmacokinetic characteristics and facilitate low dosing requirements, bypass first-pass metabolism, reduce side effects, and eliminate gastrointestinal interactions that limit bioavailability, its lead product candidate, LPCN 1021, an oral testosterone replacement therapy designed for twice-a-day dosing, is under FDA review. Lipocine’s pipeline candidates also include LPCN 1111, a next generation oral testosterone therapy product with once daily dosing that is in Phase II clinical study. LPCN 1107 is in Phase I clinical study for the prevention of recurrent preterm birth.
Product Candidate Status
LPCN 1021 (Oral Testosterone Replacement T) Clinical – Under Review
LPCN 1111 (Next Generation Oral T) Clinical – Phase II
LPCN 1107 (Prevention of Preterm Birth Clinical – Phase I
On April 13, 2016, the company will present at 3:40 pm at the Needham & Co 15th Annual Healthcare Conference.
The company presented clinical data for LPCN 1021 at the American Society of Andrology 41st Annual Conference on April 4, 2016.
The company presented clinical data for LPCN 1021 at ENDO 2016 on April 3, 2016.
On February 16, 2016, the company reported positive results for LPCN 1107.
On January 4, 2016, the company announced that the first patient had been dosed in the Phase 2B trial for LPCN 1111
The company should learn whether their first product, LPCN 1021, will be approved by the PDUFA date of June 28, 2016. LPCN 1021 is an oral testosterone agent that is designed to replace existing therapies which are typically topical creams which can lead to inadvertent transfer or injectable delivery which is a less desirable method for patients.
Vanda Pharmaceuticals Inc. (NASDAQ – VNDA)
Vanda Pharmaceuticals Inc. is developing important new medicines to improve the lives of patients. The company uses new technologies, including genetics and genomics, to inform the drug discovery, clinical trials, and commercial positioning of their compounds. They are working to advance the science of developing new medicines and to use novel approaches to deliver these new medicines to patients.
Fanapt is an atypical antipsychotic approved for the treatment of schizophrenia in adults. It was granted US market approval by the FDA in May 2009.
HETLIOZ is a melatonin receptor antagonist approved by the FDA for the treatment of Non-24-Hour Sleep-Wake Disorder. Non-24 is a chronic, circadian rhythm disorder resulting from the misalignment of the endogenous master body clock to the 24-hour day, disrupting the sleep-wake cycle. This disorder affects the majority of totally blind individuals and it is estimated that approximately 80,000 Americans have Non-24.
Tradiptant is being evaluated in a Phase II study in treatment resistant pruritus in atopic dermatitis. It has demonstrated proof-of-concept in alcohol dependence in a study published by the NIH. In the study, Tradiptant was shown to reduce alcohol cravings and voluntary alcohol consumption among patients with alcohol dependence.
On February 10, 2016, Vanda reported 4th quarter 2015 results. The company reported revenues of $109.9 million for the full year. HETLIOZ sales grew 246% to $44.3 million and Fanapt sales were $65.6 million. The company expects 2016 sales from HETLIOZ and Fanapt of between $143 million and $153 million.
Vanda has been showing strong revenue growth and the company has a PDUFA date of May 27, 2016, for a supplemental New Drug Application for Fanapt as a maintenance treatment of schizophrenia in adults. If the company is able to gain approval for this new indication, it could revive the growth in sales of Fanapt.
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