(Filing, 10-K, Aeolus, DEC 18, 2015, View Source [SID:1234508612])

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On December 18, 2015 Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) reported that the company has changed its name to Ionis Pharmaceuticals, Inc (Press release, Ionis Pharmaceuticals, DEC 18, 2015, View Source;p=irol-newsArticle&ID=2124010 [SID:1234509110]). Ionis (pronounced "eye-OH-nis") Pharmaceuticals is an original name that the Company has chosen to represent its innovative culture and heritage as both the pioneer and leader in the RNA-targeted therapeutic space for the past 26 years. Ionis is focused on bringing its late-stage Phase 3 drugs, nusinersen, volanesorsen and IONIS-TTRRx to the market and advancing its pipeline of high value drugs that have the potential to be first-in-class or best-in-class drugs to treat patients with life-threatening or serious diseases.
Ionis Pharmaceuticals

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"Our goal is to create medicines that will save patients’ lives, and we are proud to be at the forefront of creating innovative medicines," said Lynne Parshall, chief operating officer at Ionis Pharmaceuticals. "We decided to change our company name because, when people see or hear our name, we want them to think about the life-saving medicines we are developing."

In conjunction with the corporate name change, the Company will trade on the NASDAQ Global Select Market under the new ticker symbol "IONS". The new ticker symbol will become effective at the open of the market on December 22, 2015. In addition, the Company will have a new website address: www.ionispharma.com.

On December 18, 2015 Midatech Pharma reported that it has entered into an agreement to acquire Zuplenz (ondansetron), a marketed anti-emetic oral soluble film from Galena Biopharma for the prevention of chemotherapy-induced nausea and vomiting (CINV), radiotherapy-induced nausea and vomiting (RINV), and post-operative nausea and vomiting (PONV), (the "Acquisition") (Press release, Midatech, DEC 18, 2015, View Source [SID:1234508918]).

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Zuplenz, launched in the United States in July 2015, is an anti-emetic, which does not need to be injected or swallowed, offering patients a differentiated alternative. Midatech expects that the acquisition of Zuplenz will leverage its commercial infrastructure in the United States, following the acquisition of DARA BioSciences, and is complementary to Midatech’s three existing marketed oncology products. With patent protection until at least 2029, Zuplenz is targeting an estimated $4.6bn market by 2018[1] and is expected to add to Midatech’s growing revenues.

Midatech will pay a total up front consideration of $3.75 million in cash, with further cash payments, totalling up to $26 million, becoming payable if certain sales milestones are achieved, which are expected to be self-financed by milestone-generated cashflow. Following the Acquisition, Management expects cash reserves to be c.£16 million at the financial year-end. The transaction is expected to be completed on or prior to Thursday, December 24, 2015, subject to customary closing conditions.

Since closure of the DARA BioSciences acquisition, significant integration has already occurred and the resultant benefits are already evident in the enlarged group with increased revenues.

Commenting on the announcement, Dr. Jim Phillips, CEO of Midatech Pharma, said: "The acquisition of Zuplenz is a highly-complementary addition to our newly-acquired, marketed oncology portfolio. With Zuplenz expected to add to our fast-growing revenue, we believe this acquisition will help drive the Group further towards profitability."

On December 18, 2015 The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) reported that it recommended nine new medicines for marketing authorisation at its December 2015 meeting (Press release, Curis, DEC 18, 2015, View Source;mid=WC0b01ac058004d5c1 [SID:1234508641]). This brings the total number of medicines recommended for approval by the CHMP in 2015 to 93.

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The CHMP recommended granting a conditional marketing authorisation for Tagrisso (osimertinib) for the treatment of non-small cell lung cancer (NSCLC). The Committee reviewed Tagrisso under EMA’s accelerated assessment program. Conditional approval and accelerated assessment are two of the Agency’s main mechanisms to facilitate earlier access by patients to medicines that fulfil unmet medical needs. For more information, please see the press release in the grid below.

Another medicine for NSCLC, Portrazza (necitumumab), also received a positive opinion from the Committee.

Neofordex (dexamethasone), a medicine with an orphan designation, received a positive opinion for the treatment of symptomatic multiple myeloma. Neofordex was submitted as a hybrid application. This type of application relies in part on the results of studies carried out with a reference product and in part on new data.

The CHMP recommended granting a marketing authorisation for Feraccru (ferric maltol) for the treatment of iron deficiency anaemia in patients with inflammatory bowel disease.

Zurampic (lesinurad) received a positive opinion from the Committee for the treatment of hyperuricaemia (an excess of uric acid in the blood).

The CHMP recommended granting a marketing authorisation for Vaxelis, a vaccine against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type B.

Iblias and Kovaltry (octocog alfa) received positive opinions for the treatment and prophylaxis of bleeding in patients with haemophilia A. These are duplicate applications, meaning that the company provided the same sets of clinical data to support the marketing authorisation applications of both medicines.

One generic medicine received a positive opinion from the Committee: Caspofungin Accord (caspofungin) for the treatment of fungal infections.

Negative opinion on new medicine

The CHMP adopted a negative opinion for Dropcys (mercaptamine hydrochloride) which was intended to prevent and treat cystinosis affecting the eye. For more information, please see the questions-and-answers document in the grid below.

Six recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Brilique, Nplate, Revolade, Tarceva and two extensions of indication for Cyramza.

New advice for doctors and patients on Gilenya

The CHMP gave new advice for doctors and patients to minimise the risk of progressive multifocal leukoencephalopathy (PML) and basal cell carcinoma in patients treated with the multiple sclerosis medicine Gilenya (fingolimod). For more information, please see the public health communication in the grid below.

Update on Xarelto

The CHMP is currently evaluating whether a defect with a blood clotting test device used in a study of the anti-clotting medicine Xarelto (rivaroxaban) had an impact on the study results. The study, called ROCKET-AF, was used to support the approval of Xarelto for patients with non-valvular atrial fibrillation (a type of irregular heartbeat). The CHMP expects to conclude its assessment in the first quarter of 2016. Once finalised, the CHMP assessment report will be made public.