Wed, Aug. 19, 4:29 PM
- The FDA designates BioMarin Pharmaceutical's (NASDAQ:BMRN) drisapersen a treatment of a rare pediatric disease, in this case Duchenne muscular dystrophy. The agency's definition pertains to pediatric diseases affecting fewer than 200K Americans.
- Under the Rare Pediatric Disease Priority Review Voucher program, a company that receives approval for such a drug is eligible to receive a voucher that can be redeemed to obtain priority review for a subsequent marketing application for a different product. The voucher may be sold or transferred an unlimited number of times. The vouchers are quite valuable. United Therapeutics (NASDAQ:UTHR) just sold one to AbbVie (NYSE:ABBV) for $350M.
- Drisapersen is also designated an Orphan Drug and a Breakthrough Therapy to be reviewed under Fast Track and Priority Review protocols.
- Orphan Drug status provides for a seven-year period of market exclusivity for the indication, if approved.
- Previously: United Therapeutics sells Priority Review Voucher to AbbVie for $350M (Aug. 19)
Wed, Aug. 19, 7:17 AM
- AbbVie (NYSE:ABBV) buys United Therapeutics' (NASDAQ:UTHR) Rare Pediatric Disease Priority Review Voucher (PPRV) for $350M in cash. United was awarded the voucher when the FDA cleared Unituxin (dinutuximab) for the treatment of neuroblastoma in March.
- The main benefit of the voucher, which can be bought and sold an unlimited amount of times, is a six-month review clock. Also, the voucher owner only has to give the FDA a short 90-day notice of its intention to use it.
Tue, Jul. 28, 6:24 AM| Tue, Jul. 28, 6:24 AM | Comment!
Tue, Jul. 28, 6:01 AM
Wed, Jun. 24, 1:43 PM
- Screen criteria: market cap >=$1B; average daily turnover >=400K shares; % change in mutual fund ownership (most recent qtr) >=0%; PEG ratio: <=1.0.
- (EVHC -0.8%)(ESRX -0.3%)(GILD -0.2%)(JAZZ -1.3%)(KANG -1.5%)(MOH -0.4%)(MYL -0.3%)(SHPG -1%)(UTHR -3.6%)(VRX -1.4%)(ZTS -1.2%)
- This is not a list of Buy/Sell recommendations, but rather a targeted list of stocks that may be suitable for more in-depth research.
Wed, May 20, 5:41 PM
Tue, Apr. 28, 7:31 AM
- United Therapeutics (NASDAQ:UTHR) Q1 results ($M): Total Revenues: 327.5 (+26.3%); Product Sales: 325.9 (+14.5%); Operating Expenses: 321.5 (+645.9%); Net Income: (16.6) (-112.1%); EPS: (0.36) (-114.8%); Non-GAAP EPS: 2.55 (+36.4%).
- Sales by Product: Remodulin: 146.3 (+7.5%); Tyvaso: 113.4 (+5.9%); Adcirca: 45.4 (+9.7%); Orenitram: 20.9.
- No guidance provided in press release.
Tue, Apr. 28, 6:03 AM
Mon, Apr. 27, 4:38 PM
Tue, Mar. 10, 12:34 PM
- The FDA approves United Therapeutics' (UTHR +0.4%) Unituxin (dinutuximab) injection, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line therapy.
- Neuroblastoma is the most common extracranial solid cancer in children and the most common cancer in infancy, affecting ~700 patients each year. About half are diagnosed as high-risk.
- Unituxin, a maintenance therapy for neuroblastoma, is a chimeric biologic antibody that induces cell lysis (breakdown) of GD2-expressing cells. GD2 is an attractive target for cancer immunotherapies since it is strongly expressed in tumors of neuroectodermal origin while highly restricted on normal cells.
Mon, Mar. 9, 5:21 PM
- Rehovot, Israel-based SteadyMed (Pending:STDY) is set for its IPO of 4.25M shares of common stock at $12 - 14. Underwriters over-allotment is an additional 637.5K shares.
- The specialty pharmaceutical company focuses on the development and commercialization of therapeutics that address the limitations of market-leading products in certain orphan and other well-defined, high-margin specialty markets. Its lead product candidate is Trevyent, a small, pre-filled, single-use device that delivers parenteral treprostinil (Remodulin) at a pre-programmed rate to patients with pulmonary arterial hypertension. Its value proposition is a more convenient dosing regimen enabled by its PatchPump technology which delivers a steady flow of drug to the patient either intravenously or subcutaneously.
- The company intends to apply for Orphan Drug designation with the FDA by mid-year and submit an New Drug Application (NDA) by Q1 2016.
- Net losses for 2014, 2013 and 2012 were ($19.0M), ($7.9M) and ($4.1M), respectively. Operations consumed $13.4M in cash in 2014 and $7.5M in 2013.
- Related ticker: (NASDAQ:UTHR)
Thu, Mar. 5, 8:52 AM
- AbbVie's (NYSE:ABBV) extraordinarily generous buyout of Pharmacyclics (NASDAQ:PCYC) is a crystal clear example of how keen big pharma is to boost its prospects with biotech drugs with blockbuster potential. The transaction's $20B tab, backing out PCYC's $1B cash balance, values Imbruvica (ibrutinib) at $40B since Pharmacyclics' commercial partner Johnson & Johnson (NYSE:JNJ) gets 50% of Imbruvica's revenue. This implies a multiple of almost 7x Imbruvica's projected peak sales of $6B. By comparison, Amgen's (NASDAQ:AMGN) takeout of Onyx Pharma and Sanofi's (NYSE:SNY) takeout of Genzyme were both at 5x premiums.
- The looming patent expiration for Humira ($12.5B in sales the past four quarters) undoubtedly provided AbbVie extra incentive to get the deal done.
- Adding 50% of Imbruvica's sales to AbbVie's top line should increase its revenue growth 3 - 7% and EPS growth 8 - 11% through 2020.
- According to RBC analyst Michael Yee, other biotechs on the big ticket acquisition radar are: BioMarin Pharmaceuticals (NASDAQ:BMRN), Dyax (NASDAQ:DYAX), Esperion Therapeutics (NASDAQ:ESPR), United Therapeutics (NASDAQ:UTHR), Vertex Pharmaceuticals (NASDAQ:VRTX), Intercept Pharmaceuticals (NASDAQ:ICPT), Juno Therapeutics (NASDAQ:JUNO), Kite Pharma (NASDAQ:KITE), PTC Therapeutics (NASDAQ:PTCT) and Receptos (NASDAQ:RCPT).
Tue, Feb. 24, 1:37 PM| Tue, Feb. 24, 1:37 PM | Comment!
Tue, Feb. 24, 6:01 AM
Mon, Feb. 23, 5:30 PM
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Mon, Feb. 9, 12:21 PM
- The following are healthcare companies whose after-tax margins have expanded the past three quarters and trade at least 500K shares per day:
- (ACOR -0.7%)(BCR -1.5%)(BIIB -0.2%)(CAH -1.2%)(CPHD +1.3%)(EVHC -1.6%)(ILMN +0.7%)(JAZZ -1.7%)(LCI +7.3%)(MNK -0.5%)(SHPG -2.9%)(SYK -0.2%)(TMO -0.7%)(UTHR +1.4%)(VRX).
- This is not a list of "Buy" recommendations, but rather a targeted list of firms that may be suitable for more in-depth research.
UTHR vs. ETF Alternatives
United Therapeutics Corp is a biotechnology company. The Company is engaged in thedevelopment and commercialization of products to address the unmet medical needs of patients with chronic and life-threatening conditions.
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