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Daniel Lauchheimer
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Investor with no formal training. Enjoy reading about happenings in corporate America, and trying to predict where things will land in the future. Interested specifically (but not limited to) Healthcare, and Real Estate. Also interested in macro strategies, and derivatives-- both for investing... More
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  • Pharma Friday Special: Highlights From The ASCO Conference

    Roche's (OTCQX:RHHBY) tried to broaden the label for their blockbuster cancer drug Avastin. Avastin works by starving tumors of their blood supply, a strategy called anti-angiogenesis. The FDA has approved Avastin for colorectal, lung, kidney, and brain cancers. In Europe it also has approval for ovarian and breast cancers -- approval it did not receive from the FDA. Roche wants to expand the label to include glioblastoma and cervical cancer. Roche showed positive results for the cervical drug application, boosting the overall median survival rate to 17 months from 13.3 months for the chemo-only group, and offering higher rate of tumor shrinkage; 48% to 36%.

    Bayer (OTCPK:BAYRY) and Onyx (NASDAQ:ONXX) tried to broaden the label for Nexavar to include it for treatment-resistant thyroid tumors. The drug took the survival median to 10.8 months from 5.8.

    Currently the drug has approval for kidney cancer and liver cancer, with sales of $900mm. According to analysts a broadening of the label would increase revenue by $300mm.

    Eli Lilly (NYSE:LLY) announced that its lung cancer drug Alimta did not hit its primary endpoints of showing improved progression-free survival without grade four adverse events in a comparison study. Lily continues to try and maintain patent protection through a method-of-use patent, but analysts remain skeptical of the success of such an approach.

    Bristol Myers (NYSE:BMY) announced positive results for its PDL-1 immunotherapy drug nivolumab for melanoma. In the study presented close to a third of the patients in the study experienced tumor shrinkage, compared to a historical trend rate of 5% to 10% for Yervoy, the current standard of care. Survival among more than 100 melanoma patients was 16.8 months. Until a few years ago, average survival for advanced melanoma was as little as six months. Additionally, BMS showed a study that Yervoy combined with Sanofi's (NYSE:SNY) Leukine yielded better results than Yervoy alone. Other companies developing drugs in the PD-1 space include Merck (NYSE:MRK) and Roche (OTCQX:RHHBY). Targeting the PD-1 receptor unleashes a T-cell attack on cancer cells, essentially deactivating a cloaking mechanism that has prevented an immune response

    Amgen showed positive interim PhIII results for its melanoma drug T-Vec. T-Vec's mechanism of action invades tumor cells and then cause them to self-destruct while triggering an immune assault on the cancer

    AstraZeneca's (NYSE:AZN) said that their treatment for melanoma of the eye -- selumetinib shrank tumors in half of all treated patients and doubled progression-free survival. The average time it took for the disease to progress was 15.9 weeks in the selumetinib-treated patients, compared with seven weeks in the temozolomide (standard of care) arm. Melanoma of the eye effects 2,000 patients a year, and has no available cure.

    Tags: RHHBY, BMY, MRK, AZN
    Jun 07 1:33 AM | Link | Comment!
  • Pharma Friday 5/25-5/31

    M&A Etc.

    1. AZN is paying $12.70 a share for Omthera, or $323 million, along with up to $120 million in contingent value rights, based on the success of Omthera's omega-3 drug Epanova. Will compete with, GlaxoSmithKline (NYSE:GSK) Lovaza -- $559mm, and Amarin's (NASDAQ:AMRN) Vascepa
    2. PharmAthene (NYSEMKT:PIP) sued Siga Technologies (NASDAQ:SIGA) because it violated promises to negotiate in good faith over a license for ST-246, an antiviral drug for use in case of a biological attack. In its lawsuit, PharmAthene argued it had a claim to ST-246's profits because it helped fund the drug's development and Siga reneged on promises to grant a licensing agreement. This dispute stems from the fact that Siga won a five-year U.S. government contract for 2 million doses of ST-246 in a deal that could be worth as much as $2.8 billion
    3. GlaxoSmithKline Plc (GSK) acquired Okairos AG, a development stage Swiss vaccine company, for 250 million euros ($324 million). Okairos uses viruses to deliver genetic material into cells, stimulating the immune system
    4. Amgen (NASDAQ:AMGN) has entered into a long-term collaboration with Astellas Pharma (OTCPK:ALPMF) and will form a joint venture with the Japanese drugmaker to provide new medicines in Japan. Amgen will initially own 51 percent of the joint venture and it will become fully owned by the U.S. biotech as soon as 2020, the companies added. The companies will develop 5 Drugs together -- three late stage and two early stage. Late Stage drugs include -- cholesterol medicines called PCS-K9 inhibitors, osteoporosis treatment romosozumab, and gastric cancer medicine rilotumumab. Early stage drugs include -- AMG-337 for gastric cancer, blinatumomab, which is being tested against acute lymphoblastic leukemia and non-Hodgkin's lymphoma. Of note, Gastric Cancer is a particular problem in China. This comes on the heels of Amgen's and Zhejiang Beta Pharma JV to commercialize Amgen's Vectibix for metastatic colorectal cancer, in the Chinese market.
    5. Ophthotech has raised $175 million from Novo A/S (NYSE:NVO) to cover a pivotal late-stage study of its lead drug for wet age-related macular degeneration (NASDAQ:AMD), Fovista. $125mm will get NVO royalties in the drug, and $50mm will come in the form of series C financing. In a Phase IIb study with 449 patients, half of the patients recieved Lucentis & Fovista, and half only received Lucentis. Those receiving the combination of drugs had a 60% better letter recognition than those only receiving Lucentis.
    6. GE Healthcare ($GE) snatched up Unisyn Medical's ultrasound repair segment. The company's flagship product, FirstCall, can diagnose, repair and test ultrasound probes
    7. Sequenom ($SQNM) inked a deal to licence its technology to France's Laboratoire Cerba to expand the reach of the company's MaterniT21 Plus test, designed to noninvasively detect chromosomal abnormalities. The licence applies to France, Belgium, Luxembourg and 9 other countries in the Middle East and Africa
    8. Epizyme (NASDAQ:EPZM) -- took in ~$90mm in proceeds from an IPO on Friday. Epizyme uses epigenetics-a field of biology based on the idea of turning genes on and off without altering the underlying DNA-to create cancer drugs for small patient groups. As its name suggests, Epizyme harnesses epigenetics to target enzymes with its drugs. Still early stage, but already have partnerships with Roche and Merck for Companion diagnostic, and Celgene and Eisai for the international rights for two of its development drugs
    9. Qiagen (NASDAQ:QGEN) licenced two biomarkers recently. First, from Columbia University for FGFR-TACC fusion genes, whose expression marks glioblastoma, the most common and aggressive form of brain tumor. Second, from BC Cancer Agency for Y641 mutation of the EZH2 gene, a lymphoma-related flaw. Companion diagnostics are a key growth driver for Qiagen, CEO Peter Schatz said, and the company's personalized medicine business has swelled to about $100 million a year thanks to aggressive biomarker licensing and test development.

    Regulatory News

    1. GSK gained approval for Tafinlar and Mekinist -- a pair of melanoma drugs. Tafinlar is a BRAF inhibitor for the V600E gene mutation, and will cost $7,600 for a 30-day supply. Mekinist is a MEK inhibitor for the V600E and V600K gene mutation, and will cost $8,700 for a 30-day supply. GSK also received approval for a companion diagnostic test to see if the patient has that mutation. Analysts estimate that each could generate $350 million in revenue. 76,690 Americans will be diagnosed with melanoma this year, with roughly 9,480 dying from the disease
    2. Teleflex (NYSE:TFX) received a CE mark for its GPSCath device, designed to prop open vessels and reduce procedure times for vascular interventions
    3. Edwards Lifesciences ($EW) received a warning letter from the FDA over problems at the company's Utah facility Cardiac Surgery Systems business, which manufactures cannulae, cardioplegia catheters. The good news is that the warning letter and its attendant restrictions have no effect on Sapien, Edwards' banner transcatheter heart valve
    4. Endo Health's (NASDAQ:ENDP) testosterone drug got a CRL, citing safety concerns. The FDA advised that the company add a medication guide and other elements to cut the risk of severe adverse reactions to the injected therapy, according to the company's release. Yet the company saw no mention of additional clinical study requirements, and Endo's chief scientist Ivan Gergel said the company plans to respond to the agency's requests by the end of the third quarter

    Earnings News

    1. Omnivision (NASDAQ:OVTI) reported revenue of $336.2mm, an $18mm beat , and EPS of 17 cents, a 4 cents miss
    Jun 02 1:13 AM | Link | Comment!
  • Pharma Friday 5/17-5/25

    A weekly roundup of news from the pharma industry.

    Earnings

    1. Medtronic (NYSE:MDT) reported earnings this week with revenues of $4.46bn, and EPS of $1.10 a 7 cent beat. Gains led by defibrillator sales, which gained 1.5 percent to $755 million and pacemakers, which climbed 2.6 percent to $505 million. EPS guidance of $3.80-$3.85 bracketing the $3.84 a share average of 24 analysts.

    M&A

    1. Eye care company Bausch & Lomb Inc. is nearing a deal to sell itself to drug maker Valeant Pharmaceuticals International Inc. (NYSE:VRX) for about $9 billion. This deal comes on the heels of VRX's failed attempt to buy rival Actavis. VRX known as an aggressive acquirer-announcing more than 20 deals since 2011-which helps explain how it pivoted in less than a month from discussing a deal with Actavis to nearing one with Bausch & Lomb. Among its biggest deals was a combination with Biovail Corp. in 2010 and the $2.6 billion takeover of Medicis Pharmaceutical Corp. in 2012. That acquisition bolstered its position in skin-care products, a focus for Valeant.
    2. Elan (NYSE:ELN) continued its battle with Royalty Pharma (NASDAQ:RP). RP raised its offer by 12% to $6.4bn for ELN, which the ELN board rejected. Part of the RP deal stipulated that ELN shareholders reject ELN's Theravance (NASDAQ:THRX) transaction, where ELN will received royalties from THRX's lung treatments.
    3. ELN itself went on the offensive buying AOP Orphan Pharmaceuticals AG -- a rare disease manufacturer -- for 263.5 million euros, and taking a 48 percent stake in Dubai-based NewBridge Pharmaceuticals for $40 million. Finally, ELN plans to issue $800 million in debt to take advantage of attractive interest rates
    4. Actavis Inc. (NYSE:ACT), the largest U.S. maker of generic drugs by market value, agreed to acquire Warner Chilcott (NASDAQ:WCRX) for about $5 billion excluding net debt in a deal to expand in women's health and urology. Actavis is paying about 5.8x EBITDA that compares with the median of about 13 times EBITDA in a survey of almost 40 similar deals, the data show. WCRX investors will receive 0.16 shares of new Actavis stock for each Warner Chilcott share they own.
    5. Merck (NYSE:MRK) reached a deal with Goldman Sachs (NYSE:GS) to repurchase $5 billion of its shares from the investment bank. Merck will make an initial purchase of 99.5 million shares based on current market prices. Merck sold bonds last week to fund some of the share repurchases, which the company had said were to reach about $7.5 billion over 12 months.
    6. Shire (NASDAQ:SHPG) is looking at ways of giving as much as £2bn back, already have a £500mm share buy back in place announced in Q4. The maker of Adderold has been consistently targeted by large pharma firms like Bristol Meyers (NYSE:BMS).

    Regulatory

    1. XenoPort Inc. (NASDAQ:XNPT), the maker of the drug Horizant for Restless Legs Syndrome, sank the most in almost three years after an experimental medicine failed to meet goals of a late-stage clinical trial. Brian Abrahams, an analyst with Wells Fargo (NYSE:WFC), had estimated sales of $77 million by 2017 for the drug. This is disappointing, given promising phase 2 data
    2. MRK's Suvorexant -- an experimental sleep medication that blocks orexins to facilitate sleep while those for sale now work with the body's receptors that reduce neuron activity -- received word from the FDA this week that there might be issues with dosing. -- Merck says smallest doses would be 15mg, but the FDA contends that even that might not be safe. Suvorexant may generate sales of $526 million in 2017 if approved, based on the average of six analysts' estimates compiled by Bloomberg
    Tags: VRX, ACT, MDT, ELN, WCRX, XNPT
    May 26 11:13 AM | Link | Comment!
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