Loxo Oncology price target raised to $202 from $122 at Oppenheimer. Oppenheimer analyst Leah Rush Cann raised her price target for Loxo Oncology to $202 from $122 to account for an increased average forward price-to-sales multiple of the biotechnology sector. The analyst reiterates an Outperform rating on the shares.
Thursday, July 12, 2018
Wednesday, July 11, 2018
Novartis joins antibiotics exit, dumps research, cuts 140, out-licenses programs
Another Big Pharma is retreating from the antibiotics field.
Novartis today says its early-stage research group at NIBR is dropping antibacterial and antiviral research programs based in Emeryville, CA. And they’re doing it at a time that drug-resistant strains of bacteria are spreading around the world — an issue that once commanded considerable attention at Novartis.
The reorganization will trigger the layoff of about 140 staffers. Novartis noted:
The groups that are impacted in their entirety are antibacterial and antiviral research. As a result, other groups are also affected including, Pharmacology, Protein Sciences, Project Management and global support functions in Global Discovery Chemistry, NIBR Informatics, Scientific Opertions and Translational Medicine. About 150 employees will remain in the San Francisco Bay Area in support of NITD and our drug discovery efforts.
On the chopping block are a group of preclinical programs as well as LYS228, their clinical-stage effort in the field. Most of the affected staffers will have a 60-day period to work out their departure, with severance, while a small group will stay on to handle the shutdown.
Novartis added:
While the science for these programs is compelling, we have decided to prioritize our resources in other areas where we believe we are better positioned to develop innovative medicines that will have a positive impact for patients. The need for these types of medicines is clear and to maximize the chances that these programs will one day help patients we are actively engaged in out-licensing discussions with companies focused on developing medicines in these areas.
This isn’t the first time NIBR has reorganized. There was a considerable revamp shortly after Jay Bradner took the reins at the institutes. And Novartis itself is known for a restless search for cost cuts wherever it can find them — which triggered their decision to scrap a special gene and cell therapy unit and intergrate the group in the main development organization.
Pharma started bailing on antibiotics research years ago, discouraged by the notable absence of profits as generics dominated treatment. That left R&D to a small group of biotechs looking to come up with new approaches that could be used as drug-resistance become increasingly common.
The surviving players will now get a chance to pick over what is being scrapped now, just as AstraZeneca once tried to sell of their unit near Boston — until they were forced to finally spin it off as a new company.
CMS proposes $190 million raise for dialysis centers
CMS proposed boosting dialysis facilities’ pay and changing how the agency pays for durable medical equipment.
In a proposed rule released Wednesday, the CMS made some technical changes to its payment methodology for these providers. The changes will result in a 1.7%, or $190 million, increase in reimbursement. On top of that, dialysis centers should receive an additional $30 million in co-pays from Medicare beneficiaries, bringing their total pay bump to $220 million.
That’s a bigger increase than the $80 million raise dialysis centers received last year.
The agency wants to encourage providers to use new renal dialysis drugs, and proposed paying a higher Medicare rate for the treatments starting Jan. 1, 2019.
In addition, the CMS will make some tweaks to its bidding and pricing methodologies under the durable medical equipment bidding program.
The agency wants to implement what’s known as lead item bidding. Under the current bidding process, suppliers bid to set prices on powered wheelchairs as well as all of its accessories. Under the proposed change, the CMS would only accept bids for the power wheelchair and set prices for accessory items based on a fee schedule.
“This approach will streamline the bidding process for suppliers and ensure pricing is accurate,” Verma said on a call with reporters Wednesday.
The agency said the proposed changes will better help ensure Medicare enrollees get the medical equipment they need.
“Today’s proposals will help secure sustainable access to durable medical equipment and reward dialysis facilities that adopt innovative new therapies,” CMS Administrator Seema Verma said in a statement.
Michigan Says Autism And Arthritis Now Treatable By Medical Marijuana
Michigan has added several medical conditions to the state’s list of ailments which qualify for a medical marijuana prescription.
In a release by Michigan’s Department of Licensing and Regulatory Affairs (LARA), 11 “debilitating medical conditions” including autism, arthritis, Parkinson’s disease, and Tourette’s Syndrome have now been deemed treatable by LARA’s director Shelly Edgerton.
“With the changes in state law to include marihuana-infused products, and the advancement of marihuana research… I’ve added these eleven conditions to the approved list,” Edgerton said in the July 9 release.
The 11 conditions joins other serious illnesses like cancer, glaucoma, and ALS on the state’s approved marijuana list. Michigan’s full list of newly approved ailments includes:
- Arthritis
- Autism
- Chronic Pain
- Colitis
- Inflammatory Bowel Disease
- Obsessive Compulsive Disorder
- Parkinson’s
- Rheumatoid Arthritis
- Spinal Cord Injury
- Tourette’s Syndrome
- Ulcerative Colitis
11 other conditions were denied marijuana treatment by Edgerton. That list included asthma, depression, and diabetes.
“It is definitely opening the doors to be able to help many, many families. I honestly feel like it saved my son’s life,” Amie Carter told WNEM. Carter’s 11-year-old son Jayden has autism and has reportedly had major issues with behavior in the past.
“Because of cannabis oil he hasn’t any encounters with police in over a year, it changed our lives,” Carter added.
Takeda Phase 3 Med Ups Survival for Post-Transplant Melanoma Patients
Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the randomized, Phase 3 TOURMALINE-MM3 study met its primary endpoint, demonstrating single-agent oral NINLARO® (ixazomib) as a maintenance therapy resulted in a statistically significant improvement in progression-free survival (PFS) versus placebo. The trial evaluated the effect of NINLARO as a maintenance therapy in adult patients diagnosed with multiple myeloma who responded to high-dose therapy (HDT) and autologous stem cell transplant (ASCT). Takeda plans to submit data from the trial to regulatory agencies around the world. NINLARO is currently not approved as a maintenance therapy for multiple myeloma following ASCT.
“Within the maintenance setting, it is critical that we find agents that are efficacious, tolerable and convenient,” said Jesús Gomez Navarro, M.D., Vice President, Head of Oncology Clinical Research and Development, Takeda. “The results of the TOURMALINE-MM3 trial represent an important step toward the goal of expanding the use of NINLARO as a maintenance therapy. This is the first and only Phase 3 placebo-controlled study evaluating a proteasome inhibitor in this setting and we look forward to discussions with Health Authorities around the world.”
There were no new safety signals found in TOURMALINE-MM3. The safety profile of NINLARO in the maintenance setting is consistent with previously reported results of single-agent NINLARO use.
Full data results will be submitted for presentation at the 60th American Society of Hematology Annual Meeting in December.
Ferrofluid and Cancer
Ferrofluids are colloidal suspensions of magnetic particles in a liquid carrier, which become magnetized in the presence of a magnetic field. These may be composed of iron, nickel, or cobalt, and show magnetic properties.
The particles are typically about 10 nm in diameter, and may be suspended in either oil or water. Ferrofluids are also called magnetic nanoparticles (MNPs) or magnetic beads (MBs). Ferrofluids were first introduced to the world in the 1960s by NASA Lewis Laboratories and AVCO Space Systems independently.
Image Credit: Nneirda / Shutterstock
Synthesis
Nano-sized magnetic particles (e.g. iron oxide) can be synthesized in many ways. One such reaction is by co-precipitating magnetite (Fe3O4) with ammonia (NH3) from an iron solution:
2FeCl3 + FeCl2 + 8NH3+ 4H2O → Fe3O4 + 8NH4Cl
Many MNPs used in targeted delivery systems are chemically iron oxides.
Iron oxide may be directly cytotoxic due to the formation of oxygen and nitrogen free radicals. Therefore, MNPs are mostly prepared using core-shell methodology which has several advantages:
- protects the magnetic core from oxidation
- prevents the formation of aggregates and agglomerates due to Van der Waals force, hydrophobic effect, and magnetic attractions
- protects the surface from any chemical reactions (d) amplifies the cellular uptake rate, and
- facilitates various therapeutic attachments.
The magnetic core of an iron oxide nanoparticle comprises magnetite (Fe3O4) and/or maghemite (γ‑Fe2O3), whereas the coat is made up of organic compounds such as surfactants, synthetic/natural polymers, and inorganic materials like carbon, silica, oxides, or precious metals.
Ferrofluids in Cancer Therapy
Cancer is a major killer all over the world. Over the past several decades, chemotherapy, radiotherapy, and surgery have been the main components of cancer management. Such treatments possess their own advantages and disadvantages.
Both chemotherapy and radiotherapy are nonselective in their effects, affecting healthy cells as well as cancerous ones, though radiotherapy has more localized effects. Moreover, this treatment is carried out at tissue/organ level, not at cellular level; thus, the chances of causing harm to healthy cells increase.
Treating cancer by surgical removal is another successful method, but it is impossible to carry out surgery in all cases, as some locations are inaccessible, such as the deep interior of the brain or the liver. Moreover, surgery is not an option in the presence of widespread tumor metastasis.
All such conventional treatments have limited access in one or other manner, and lack selectivity of action towards tumor cells. There is much need of a technique that targets the tumor cells specifically.
Using MNPs as drug carriers in targeted cancer therapy provides good opportunities for cancer cure, as the use of such carriers reduces the side effects pertaining to conventional treatments. Medications can be targeted to treat the desired locations inside the body with the help of the magnetic properties of ferrofluids.
Magnetic Fluid Hyperthermia (MFH) Approach
MFH uses MNPs in combination with heat. It can treat tumors which lie deep within the body areas such as the bony skull (glioblastoma) and the pelvis (prostate/cervical carcinoma). The treatment involves administration of magnetic nanoparticles into the tumor followed by exposure to an alternating current (AC) magnetic field.
The cancer cells which adhere to MNPs are exposed to the alternating magnetic field (AMF), and the temperature is set above 42–46°C. Heat alters some receptor molecules on the cancer cell surface, which enhances their recognition by natural killer cells.
Superparamagnetic iron oxide nanoparticles (SPIONs) show great promise in biomedical applications as they are small enough to be used at cellular level, and display magnetic behavior only in the presence of a magnetic field.
In 2005, the first Phase 1 clinical study was conducted in patients with recurrent prostatic tumor which concluded that magnetic hyperthermia is a feasible as well as well-tolerated treatment modality.
Another study, two years later, was conducted using magnetic hyperthermia in combination with radiotherapy in 14 brain cancer patients, demonstrating that the therapy was well‑tolerated in all patients, though with minimal or no clinical benefit.
The treatment operates at cellular level rather than at the tissue or organ level, so it is able to target cancer cells selectively compared to the conventional approaches used in the treatment of tumors. In a recent study, it has been seen that a proteasome inhibitor used along with MFH can be used to treat larger tumors unlike other conventional methods.
MFH is projected to be a major breakthrough in cancer treatment, and promises to be a viable therapy for treating human tumors.
Other Applications
Other areas in which MNPs may prove to be useful include lung cancer which is notoriously difficult to treat because of the lack of adequate drug concentrations at the sites of disease. One in vitro study has used aerosols containing superparamagnetic nanoparticles of iron oxide delivered to the lung to reach effective dosage levels in the affected areas of the lung without adverse effects.
Another proposed delivery method uses magnetic targeted carriers using ferromagnetic particles below micron size, to deliver relaxant drugs during the administration of local anesthesia as well as in targeted cancer therapy.
Another area which is exploring the feasibility of MNPs is gene therapy to introduce genes into targeted cells without having to use viral and retroviral vectors, which are especially noted to be associated with adverse effects.
Reviewed by Liji Thomas, MD
Achieve Life Sciences Scores On Plan For Smoking Cessation Candidate
Achieve Life Sciences Inc ACHV 11.08% shares are skyrocketing as the clinical-stage biotech moves one step closer to filing a New Drug Application for its smoking cessation pipeline candidate cytisine.
The stock was rallying 33.15 percent to $4.82 Wednesday morning.
What Happened
After a meeting with the FDA regarding both clinical and non-clinical development plans for cytisine, Achieve Life Sciences said the Phase 3 clinical program as well as a future NDA filing are further defined.
In late June, the company reported positive results for cytisine based on a series of drug metabolism, drug-to-drug interaction and transponder studies.
Why It’s Important
Cytisine is a plant-based alkaloid which binds to the nicotinic acetylcholine receptor. It has been approved and marketed in central and eastern Europe for over 15 years and has helped over 20 million people tackle nicotine addiction, according to Achieve.
What’s Next
The company said it will conduct a Phase 2b optimization trial in about 250 smokers in the U.S., with various dosing schedules to determine efficacy, safety and compliance profiles. The primary endpoint is a reduction in cigarettes consumed during treatment.
Achieve Life Sciences said it will initiate the Phase 2b trial in Q4’18, with top-line results expected in Q2’19. The results will help define the Phase 3 study, which is planned to be initiated in 2019.
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