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10-Q – Quarterly report [Sections 13 or 15(d)]

Celgene has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Celgene, APR 30, 2015, View Source [SID1234503240]).

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10-Q – Quarterly report [Sections 13 or 15(d)]

Eli Lilly has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Eli Lilly, APR 30, 2015, View Source [SID1234503232]).

Gilead Sciences Announces First Quarter 2015 Financial Results

On April 30, 2015 Gilead Sciences, Inc. (Nasdaq: GILD) reported its results of operations for the first quarter ended March 31, 2015 (Filing, Q1, Gilead Sciences, APR 30, 2015, View Source [SID:1234506608]). The financial results that follow represent a year over year comparison of first quarter 2015 to the first quarter 2014. Total revenues were $7.6 billion in 2015 compared to $5.0 billion in 2014. Product sales were $7.4 billion in 2015 compared to $4.9 billion in 2014. Net income was $4.3 billion, or $2.76 per diluted share in 2015 compared to $2.2 billion or $1.33 per diluted share in 2014. Non-GAAP net income, which excludes amounts related to acquisition, restructuring, stock-based compensation and other, was $4.6 billion, or $2.94 per diluted share in 2015 compared to $2.5 billion or $1.48 per diluted share in 2014.

Product Sales

Total product sales for the first quarter of 2015 were $7.4 billion compared to $4.9 billion for the first quarter of 2014. In the first quarter, product sales in the U.S. were $5.2 billion compared to $3.6 billion for the first quarter of 2014, and in Europe, product sales for the first quarter of 2015 were $1.8 billion compared to $1.0 billion for the same period in 2014.

Antiviral Product Sales

Antiviral product sales increased to $7.0 billion for the first quarter of 2015, up from $4.5 billion for the first quarter of 2014 primarily due to sales of Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg), which was approved in the U.S. and Europe in the fourth quarter of 2014, partially offset by a decrease in sales of Sovaldi (sofosbuvir).

Other Product Sales

Other product sales, which include Letairis, Ranexa and AmBisome, were $417 million for the first quarter of 2015 compared to $362 million for the first quarter of 2014.

Operating Expenses

During the first quarter of 2015, compared to the same period in 2014:

Non-GAAP research and development (R&D) expenses increased primarily due to the continued progression and expansion of Gilead’s clinical studies, particularly phase 3 studies in the liver disease and oncology areas.
Non-GAAP selling, general and administrative (SG&A) expenses increased primarily due to growth in our business including commercial expansion for our hepatitis C virus (HCV) products.

As of March 31, 2015, Gilead had $14.5 billion of cash, cash equivalents and marketable securities compared to $11.7 billion as of December 31, 2014. During the first quarter of 2015, Gilead generated $5.7 billion in operating cash flow and utilized $3.0 billion to repurchase shares, which completes our May 2014 stock repurchase program.

Revised 2015 Full Year Guidance

Gilead updated its full year 2015 guidance, which it initially provided on February 3, 2015.

Product & Pipeline Updates Announced by Gilead During the First Quarter of 2015 Include:

Antiviral Program

Announced that the Japanese Ministry of Health, Labour and Welfare approved Sovaldi for the suppression of viremia in patients with genotype 2 chronic HCV infection with or without compensated cirrhosis. Sovaldi is indicated for use in combination with ribavirin (RBV) for 12 weeks. Sovaldi (in combination with RBV) is the first all-oral, interferon-free treatment regimen for genotype 2 HCV infection.

Presentation of data at the 22nd Conference on Retroviruses and Opportunistic Infections included announcement of:
Positive results from a Phase 3 clinical trial evaluating the once-daily single tablet regimen Harvoni for the treatment of genotypes 1 or 4 chronic HCV infection among patients co-infected with HIV. In the trial, 96 percent of HCV patients achieved a sustained virologic response 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV infection.

Positive 48-week results from two Phase 3 studies (Studies 104 and 111) evaluating an investigational once-daily single tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection in treatment-naïve adults. TAF is a novel nucleotide reverse transcriptase inhibitor that has demonstrated high antiviral efficacy at a dose 10 times lower than Gilead’s Viread, as well as improved renal and bone laboratory parameters, in clinical trials.

Positive results from a preclinical study conducted in collaboration with researchers at Beth Israel Deaconess Medical Center evaluating a proprietary investigational oral TLR7 agonist and analogue of GS-9620 as part of an HIV eradication strategy. Data demonstrated that treatment with the TLR7 agonist induced transient plasma Simian Immunodeficiency Virus (SIV) RNA, as well as reduced SIV DNA in virally suppressed rhesus macaques given antiretroviral therapy (ART). In addition, the study found that after discontinuation of ART, SIV viral loads were lower among macaques that received the proprietary TLR7 agonist compared to the placebo group.

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DEP™ Docetaxel Trial Dose Exceeds Common Taxotere® Dose Level

On April 30, 2015 Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) reported an update to the progress of its phase 1 clinical trial of DEP docetaxel for advanced solid cancers (Press release, Starpharma, APR 30, 2015, View Source [SID:1234506578]). The DEP docetaxel dose level now exceeds the most commonly used dose for Taxotere of 75mg/m2, with no dose limiting toxicities (DLT), including neutropenia, having been observed to date.

Approximately 50% of the anticipated number of patients have been recruited into the study and dosed with DEP docetaxel. Several patients have received multiple (up to 6) cycles of DEP docetaxel.

Available data show that DEP docetaxel has been very well-tolerated, with no observations of neutropenia to date. According to the available product information for Taxotere (currently marketed docetaxel formulation), neutropenia occurs in virtually all patients given 60mg/m2 to 100mg/m2 of Taxotere, and the most severe (grade 4) neutropenia occurs in 75% of patients given 60mg/m2 of the product. The clinical data for DEP docetaxel are in line with preclinical studies in animals that showed that DEP docetaxel eliminated the neutropenia seen with equivalent doses of docetaxel alone whilst enhancing anticancer efficacy.

There have also been no reports in the trial of vomiting or hair loss related to the DEP docetaxel treatment. By comparison these events occur in a significant proportion of patients receiving Taxotere as monotherapy.

In contrast to therapy with Taxotere, which is formulated in polysorbate-80, a detergent that can cause significant hypersensitivity reactions, patients receiving DEP docetaxel therapy do not need to receive pre-treatment with corticosteroids (cortisone) because DEP docetaxel is detergent free. Additionally, patients receiving DEP docetaxel therapy have not required prophylactic treatment with anti-emetics (to stop nausea/vomiting).

Available pharmacokinetic data show, as previously reported, that DEP docetaxel also has the benefits of longer half-life and reduced peak concentrations of docetaxel compared to when the drug is given in its native form.

Starpharma CEO, Dr Jackie Fairley, commented: "We are very pleased that the study is progressing so well. The fact that a number of patients have exhibited potential anti-cancer activity, across a range of tumor types, despite the absence of dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD) for DEP docetaxel not yet being reached, is very encouraging."

Taxotere is approved for treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric cancer and head and neck cancer. Patients with a range of advanced solid tumour types are enrolled in the current study. The study is being conducted across four Australian sites – Nucleus Network/Alfred Hospital, Austin Health/Olivia Newton John Cancer Centre, Liverpool Hospital and Royal Brisbane & Women’s Hospital.

Quarterly Cashflow Report

On April 30, 2015 Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) reported its Appendix 4C – Quarterly Cashflow report for the period ended 31 March 2015 (Press release, Starpharma, APR 30, 2015, View Source [SID:1234506577]).

Highlights
DEPTM docetaxel dosage levels exceeds the most commonly used Taxotere dose
Majority of sites in phase 3 clinical trials for VivaGel to prevent recurrent bacterial vaginosis (R-BV) recruiting participants
Regulatory submissions for VivaGel Symptomatic Relief of bacterial vaginosis
Continued Australian rollout of VivaGel condom
Increased activity in partnered drug delivery and agrochemical programs
Solid cash balance of A$34.7 million

During the quarter, activities have progressed across all of Starpharma’s programs for VivaGel, drug delivery and agrochemicals. These include the two active clinical programs – the two phase 3 clinical trials for VivaGel to prevent recurrent bacterial vaginosis (R-BV) and the phase 1 clinical trial of DEP docetaxel. The reported cash balance at 31 March 2015 of A$34.7 million supports these activities.

In drug delivery, the phase 1 clinical trial of DEP docetaxel continues to show very encouraging clinical data, with the drug remaining very well-tolerated and no neutropenia or hair loss observed to date with a number of patients having received multiple (up to 6) cycles of DEP docetaxel. Approximately 50% of the anticipated number of patients have now been recruited across four Australian sites with dose levels now above the most commonly used dose for Taxotere, a dose at which a vast majority of patients typically experience neutropenia and hair loss. A number of patients being treated with DEP docetaxel have exhibited potential anti-cancer activity, across a range of tumor types. This has been achieved despite the absence of dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD) for DEP docetaxel not yet being reached.

In the two phase 3 clinical trials for VivaGel to prevent recurrent bacterial vaginosis (R-BV), the majority of sites are now recruiting across the US, Canada, Europe, Asia and Mexico. Each trial is anticipated to enrol approximately 600 women. The phase 3 study design was agreed with the US Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA), which reduces Starpharma’s regulatory risk through achieving a binding agreement from FDA on the acceptability of the trial design and planned analyses. Starpharma has also received agreement on the trial design from the European regulatory authority.

The VivaGel condom, marketed by Ansell as LifeStyles Dual ProtectTM, represents the first marketed product for Starpharma’s VivaGel portfolio. The condom is currently available in Woolworths stores and online directly from Ansell, with new retail channels including pharmacies and other supermarket chains expected to be added in the near future. In addition, the VivaGel condom is expected to be launched in New Zealand following regulatory approval in late 2014, and regulatory activities continue in a number of other markets including Japan.

Another focus during the quarter was the preparation and filing of a marketing application with relevant regulatory authorities for VivaGel vaginal gel for the symptomatic relief of bacterial vaginosis (BV). This opportunity for certain non-US markets utilises existing data for VivaGel, including from previously completed clinical trials which showed excellent and rapid relief from BV symptoms.

The quarter has also seen momentum and escalation in the level of activity in Starpharma’s partnered programs for drug delivery and agrochemicals as candidates are advanced in development.

As these clinical and commercial opportunities in VivaGel and drug delivery advance towards important inflection points, the solid cash balance positions Starpharma well for creating significant additional value. The above activities are further supported by Starpharma’s strategy in agrochemicals, which provides broader application of Starpharma’s dendrimer technology.

Operating and investing cash outflows were A$4.9 million for the quarter. This expenditure relates to all Starpharma programs, including the two phase 3 clinical trials for VivaGel R-BV, the phase 1 clinical trial of DEP docetaxel, and regulatory activities.

"This quarter has been another period of substantial progress for Starpharma. With two exciting clinical programs underway, a high level of activity with our partnered drug delivery programs, the VivaGel condom in market and other applications underway, and a strong cash position the company is very well placed to capitalise on," said Starpharma Chief Executive Officer Dr Jackie Fairley.