Spectrum Pharmaceuticals ($SPPI), la conference call del giorno dopo (parte 1).

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two-dimensional stick model of PXD101 chemical...

Visto che il povero Belinostat non se lo fila più nessuno, lo faccio io. (Photo credit: Wikipedia)

Ecco la trascrizione della Conference Call indetta dopo l’annuncio dell’acquisizione di Allos Therapeutics ($) e del mancato raggiungimento degli endpoint primari nelle due fasi 3 di Eoquin.
La sessione delle domande e risposte (Q&A) la metto in un secondo post, altrimenti salta fuori un articolo lungo un chilometro.
Oh, mi permetto di segnare in grassetto alcuni punti importanti e di fare qualche commento… siete invitati, ovviamente, a commentare anche voi, se volete.

Rajesh C. Shrotriya, Chairman, Chief Executive Officer & President.

Thank you, Shiv, and good morning, everyone. These are exciting time to the Spectrum. Today we announced a planned acquisition of Allos Therapeutics. This represents an important and exciting opportunity for both of our companies. There are four critical takeaways for our investors.

Number one, this is a good deal for shareholders of both companies. The deal brings immediate diversification from a revenue-generating cancer drugs and is expected to be rapidly accretive to EPS in fourth quarter of this year.

Number two, there is unique synergy in a combination of Allos and Spectrum, is prescribed by the same target physicians as ZEVALIN, while FUSILEV maybe helpful in reducing toxicity of FOLOTYN.

Number three, we believe FOLOTYN’s potential extends beyond PTCL. Remember, it is an improved methotrexate analog. And methotrexate is used to treat a variety of both liquid and solid tumors, such as breast cancer, acute lymphocytic leukemia and others.

Number four, in keeping with our philosophy of strong fiscal discipline, we don’t anticipate issuing even a single share of our stock to complete this transaction and that’s very important to us. I will now cover these points in greater depth. This acquisition further diversifies the Spectrum’s product revenue with an FDA approved novel anticancer drug, FOLOTYN, which is prescribed by the same physicians who prescribe .

In sostanza i 4 aspetti fondamentali che il CEO illustra come un valore aggiunto per gli azionisti sono: diversificazione della pipeline immediata, Folotyn viene prescritto dallo stesso tipo di medici che già ora sono stati contattati da Spectrum per promuovere la vendita di Zevalin, il potenziale del farmaco sviluppato da Allos (ALTH) si estende oltre l’impiego in pazienti affetti da PTCL (linfoma periferico a cellule T) inoltre Spectrum non ha emesso una singola azione per finanziare questa acquisizione.

Ora, riguardo al primo punto non ho nulla da obiettare, si trattava di un aspetto che comunque mi era già piaciuto quando annunciarono la licenza per Belinostat, stessa coso per i target di oncologi ai quali Spectrum si rivolgerà. Sul fatto che l’operazione sia stata condotta senza emettere nuove azioni… finora, aggiungo io. Si potrebbe sempre discutere sull’opportunità di investire su di un farmaco differente, con meno affinità verso quelli già in pipeline, ma di questo e delle possibilità di Folotyn oltre il PTCL parlerò dopo.

Continua…

FOLOTYN is the very first drug approved by the FDA in 2009 for treating a fatal disease called relapsed or refractory peripheral T-cell lymphoma or commonly known as PTCL. FOLOTYN will complement our existing marketed drugs, ZEVALIN and FUSILEV, which delivered $193 million of revenues in 2011.

FOLOTYN was approved in the United States in September 2009, launched in January 2010 and net sales of FOLOTYN were $50.5 million (sic) [$50 million] (05:33) last year. PTCL is a fatal disease for which clinicians had no FDA approved treatment options until the approval of FOLOTYN by the FDA.

The total U.S. market for second line PTCL is estimated to be approximately $400 million, with the total U.S. relapsed, refractory PTCL treatable population estimated to be approximately 10,000 patients each year.

We expect FOLOTYN’s annual sales could reach excess of $100 million. We believe the acquisition of Allos and the addition of FOLOTYN to our revenue generating portfolio will enable Spectrum to continue to increase shareholder value. This acquisition will accelerate the development of our anticancer franchise and affirms our commitment to being a leader in the treatment of lymphoma.
The ZEVALIN and FOLOTYN are highly synergistic because they are used by the same physicians for the treatment of different forms of lymphoma. We are well positioned to leverage our combined commercial infrastructure while expanding the number of patients that can potentially benefit from our drug.

Ora, gli aspetti chiave sono che nello scorso anno Allos ha generato 50 milioni di dollari dalle vendite di Folotyn (contro i 30 dell’anno 2009) e che Spectrum conta di raddoppiare le vendite e di posizionarsi come una compagnia leader nel trattamento dei linfomi. Come?

A mio modo di vedere si passa attraverso due strade parallele: i team di vendita di Spectrum e di Allos devono lavorare in sinergia, sfruttando uno le conoscenze dell’altro e la compagnia deve portare avanti la ricerca sui farmaci in combinazione, quanto Belinostat faccia parte dei piani futuri della società è ancora da stabilire. Finora nella trascrizione il farmaco preso in licenza da Topotarget non è stato ancora nominato.

Spectrum is expecting a smooth transition and integration; we’ve carefully evaluated the synergies and have identified areas of redundancy to create a more cost effective structure for the combined company. We expect to achieve $40 million to $50 million in cost synergies in the very first year after closing. This acquisition is expected to be accretive on a cash basis to Spectrum starting in the fourth quarter of 2012.

We believe the benefits of this acquisition extend well beyond the cost related synergies. For instance, FOLOTYN and anti-folate coupled potentially by combined – can be combined with FUSILEV, which is a novel folic acid replacement, addressing toxicity of FOLOTYN such as mucositis. We believe Spectrum can break down barriers to further adoption of FOLOTYN.

Qui si ripropone il discorso di utilizzare farmaci in combinazione, nel caso specifico Fusilev come, tra gli altri aspetti, mitigante della tossicità di Folotyn. Ancora nessun cenno a Belinostat.

Our combined sales force, we cross-promote these two innovative products to the same physicians. We have deep knowledge of the disease area among our regulatory, clinical, marketing and sales team. I’m also pleased to report that because of our strong operating performance, cash reserves, fiscal discipline and a revolving credit line, we do not need to issue any equity to close this transaction. We anticipate the transaction will be accretive to EPS in Q4 of 2012.

In closing, I’m excited by the opportunity we have ahead of us and confident in our ability to execute. This transaction will provide an additional long-term growth driver to our existing oncology franchise. It will deliver revenue immediately and allow us to address the significant unmet needs faced by patients suffering from cancer.

I will now turn the call over to Brett to discuss the financial terms of our agreement.

Ecco ora gli aspetti finanziari dell’accordo.

Brett L. Scott, Acting Chief Financial Officer & Senior VP

Thank you Dr. Shrotriya. First, I need to be clear that this announcement is neither an offer to purchase nor a solicitation of an offer to sell Allos Therapeutics shares. The tender offer will only be made through an offer to purchase letter of transmittal and related tender offer materials. At the time, the expected offer is commenced, Spectrum Pharmaceuticals will file these tender offer materials with the Securities and Exchange Commission and Allos Therapeutics will file a solicitation/recommendation statement with respect to the offer.

The tender offer materials and the solicitation/recommendation statement will contain important information. Stockholders are urged to read this information carefully before making any decision about the tender offer. The tender offer materials, certain other offer materials, and the solicitation/recommendation statement will be sent free of charge to all stockholders of Allos Therapeutics at their request.

With that said, I would like to walk through the transaction terms. Under the agreement, Spectrum will commence a tender offer to purchase all of the outstanding shares of Allos for $1.82 in cash plus one Contingent Value Right or CVR. The CVR will entitle each Allos stockholder to an additional payment of $0.11 per share in cash if FOLOTYN obtains approval for the treatment of patients with relapsed/refractory PTCL in Europe in 2012 and achieves its first reimbursable commercial sale in at least three major European Union markets by December 31, 2013.
Spectrum Pharmaceuticals plans to finance the transaction through cash on hand and a committed revolving credit line from Bank of America. The acquisition is expected to be accretive to Spectrum on a cash basis in the fourth quarter of 2012. We anticipate that the tender offer will be completed in the second quarter of 2012 subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other standard conditions typical of deals of this size and scope. We’re very excited about the agreement to acquire Allos Therapeutics. We look forward to rapidly integrating the company and strengthening our position in hematology.

Il CVR darà diritto al pagamento ad ogni azionista di Allos di 0,11$ ad azione al raggiungimento dell’obiettivo prefissato, l’approvazione in Europa del farmaco per il trattamento del PTCL entro il 31 dicembre 2013. Se avete letto gli articoli precedenti saprete che la domanda di approvazione è ora sotto nuovo esame del CHMP, dopo che una prima opinione negativa è stata espressa. Se tale giudizio venisse confermato, non ci sarebbe materialmente il tempo di condurre un nuovo trial e di presentare la domanda entro la scadenza, quindi il tutto sarebbe legato al reperimento di dati su pazienti già trattati, in un modo piuttosto simile a quello utilizzato per l’approvazione di Fusilev.

Ok, queste sono le fasi 3 che coinvolgono Folotyn:

Rank Status Study
1 Recruiting Study of Pralatrexate Versus Observation Following CHOP-based Chemotherapy in Previously Undiagnosed Peripheral T-cell Lymphoma Patients

Condition: Peripheral T-cell Lymphoma
Interventions: Drug: Pralatrexate Injection; Dietary Supplement: Vitamin B12; Dietary Supplement: Folic Acid
2 Recruiting Alisertib (MLN8237) or Investigator’s Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma

Conditions: Relapsed Peripheral T-Cell Lymphoma; Refractory Peripheral T-Cell Lymphoma
Interventions: Drug: Alisertib; Drug: Pralatrexate; Drug: Romidepsin; Drug: Gemcitabine

Si tratta sempre di PTCL, quindi di registrativo in fase 3 che possa allargare l’impiego del farmaco ad altre tipologie di linfomi, nulla.

Vediamo invece le fasi 2 condotte sia da Allos che da enti pubblici che coinvolgono il Pralatrexato (cioè Folotyn):

Rank Status Study
1 Completed
Has Results
Study of Pralatrexate vs. Erlotinib for Non-Small Cell Lung Cancer After at Least 1 Prior Platinum-based Treatment

Condition: Non-small Cell Lung Cancer
Interventions: Drug: Pralatrexate Injection; Drug: Erlotinib; Dietary Supplement: Vitamin B12; Dietary Supplement: Folic Acid
2 Completed Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies

Conditions: Relapsed or Refractory Lymphoproliferative Malignancies; Hodgkin’s Lymphoma; Peripheral T-cell Lymphoma; B-cell Lymphoma; Waldenstrom’s Macroglobulinemia
Interventions: Drug: Pralatrexate Injection; Drug: Gemcitabine Hydrochloride; Dietary Supplement: Vitamin B12; Dietary Supplement: Folic Acid
3 Active, not recruiting
Has Results
Study of Pralatrexate With Vitamin B12 and Folic Acid in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma

Condition: Peripheral T-cell Lymphoma
Intervention: Drug: Pralatrexate Injection
4 Recruiting Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer

Conditions: Adenocarcinoma of the Esophagus; Adenocarcinoma of the Gastroesophageal Junction; Diffuse Adenocarcinoma of the Stomach; Intestinal Adenocarcinoma of the Stomach; Mixed Adenocarcinoma of the Stomach; Recurrent Esophageal Cancer; Recurrent Gastric Cancer; Squamous Cell Carcinoma of the Esophagus; Stage III Esophageal Cancer; Stage III Gastric Cancer; Stage IV Esophageal Cancer; Stage IV Gastric Cancer
Interventions: Drug: pralatrexate; Drug: oxaliplatin; Other: pharmacogenomic studies; Genetic: RNA analysis; Genetic: polymorphism analysis; Genetic: polymerase chain reaction; Genetic: microarray analysis; Procedure: esophagogastroduodenoscopy; Procedure: biopsy; Other: laboratory biomarker analysis
5 Recruiting Study of Pralatrexate With Vitamin B12 and Folic Acid Supplementation for Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)

Condition: Head and Neck Cancer
Intervention: Drug: Pralatrexate With Vitamin B12 and Folic Acid
6 Recruiting Study of Pralatrexate to Treat Patients With Relapsed or Refractory B-cell Non-Hodgkin’s Lymphoma

Condition: Lymphoma, B-Cell
Interventions: Drug: Pralatrexate Injection; Dietary Supplement: Vitamin B12; Dietary Supplement: Folic Acid
7 Completed Study of Pralatrexate to Treat Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder

Conditions: Carcinoma, Transitional Cell; Bladder Cancer; Bladder Neoplasm
Interventions: Drug: Pralatrexate Injection; Dietary Supplement: Vitamin B12; Dietary Supplement: Folic Acid
8 Active, not recruiting Study of Pralatrexate in Female Patients With Previously-treated Breast Cancer

Conditions: Breast Cancer; Breast Tumors; Neoplasms, Breast; Cancer of the Breast; Human Mammary Carcinoma
Interventions: Drug: Pralatrexate Injection; Dietary Supplement: Vitamin B12; Dietary Supplement: Folic Acid
9 Recruiting Pralatrexate and Docetaxel in Treating Patients With Stage IV Esophageal or Gastroesophageal Cancer Who Have Failed Platinum-Based Therapy

Conditions: Adenocarcinoma of the Esophagus; Adenocarcinomas of the Gastroesophageal Junction; Recurrent Esophageal Cancer; Squamous Cell Carcinoma of the Esophagus; Stage IV Esophageal Cancer
Interventions: Drug: pralatrexate; Drug: docetaxel; Radiation: fludeoxyglucose F 18; Procedure: positron emission tomography
10 Recruiting Combination Chemotherapy and Pralatrexate as First-Line Therapy in Treating Patients With Non-Hodgkin Lymphoma

Conditions: Anaplastic Large Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Hepatosplenic T-cell Lymphoma; Peripheral T-cell Lymphoma
Interventions: Drug: prednisone; Drug: cyclophosphamide; Drug: etoposide; Drug: vincristine sulfate; Drug: pralatrexate; Other: laboratory biomarker analysis; Genetic: comparative genomic hybridization; Genetic: gene expression analysis; Genetic: nucleic acid sequencing; Genetic: mutation analysis; Other: immunohistochemistry staining method; Genetic: microarray analysis; Genetic: RNA analysis
11 Recruiting Phase II of Carbo/Pralatrexate in Rec. Platinum-Sensitive Ovarian, Fallopian or Primary Peritoneal Cancer

Conditions: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer
Interventions: Drug: carboplatin; Drug: pralatrexate
12 Completed 10-Propargyl-10-Deazaaminopterin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Condition: Lung Cancer
Intervention: Drug: pralatrexate
13 Completed 10-Propargyl-10-Deazaaminopterin in Treating Patients With Recurrent or Refractory Non-Hodgkin’s Lymphoma or Hodgkin’s Lymphoma

Condition: Lymphoma
Intervention: Drug: pralatrexate

Qui già cominciamo ad esserci, oltre ai linfomi, ci sono tumori solidi. Tumori del collo e della testa con istologia squamosa (HNSCC), carcinoma del polmone non a piccole cellule (NSCLC), cancro alla vescica e al seno.

Fra gli studi chiusi all’arruolamento e con risultati, cioè quelli che avrebbero la possibilità di dare origine ad una fase 3 in una indicazione diversa dal PTCL, quelli riguardanti il cancro al polmone sono quelli suscitano maggiore interesse.

Sono questi:

Rank Status Study
1 Completed
Has Results
Study of Pralatrexate vs. Erlotinib for Non-Small Cell Lung Cancer After at Least 1 Prior Platinum-based Treatment

Condition: Non-small Cell Lung Cancer
Interventions: Drug: Pralatrexate Injection; Drug: Erlotinib; Dietary Supplement: Vitamin B12; Dietary Supplement: Folic Acid
2 Completed 10-Propargyl-10-Deazaaminopterin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Condition: Lung Cancer
Intervention: Drug: pralatrexate

Folotyn funziona? Il primo studio che ho segnato qui sopra è una fase 2 randomizzata ed open label (cioè tutti sanno che farmaco viene somministrato) che confronta Folotyn e Tarceva su 201 pazienti con NSCLC di grado IIIb/IV. I dati hanno mostrato una riduzione del rischio di morte del 16% nel braccio di Folotyn, ma il dato non è statisticamente significato. Oh, che il trial non dia dati significativi in fase 2 ci potrebbe anche stare, ma qui il numero di pazienti è piuttosto elevato…

I dati risalgono al 2010, quindi o non sono stati sufficienti per disegnare una fase 3 con possibilità di successo, o Folotyn non è efficace quanto Tarceva.

Ora, tutto quello che riguarda le sperimentazioni in corso, non dovrebbe cambiare. Per quelle future, ricordiamoci tutti che c’è di mezzo Mundipharma.

Oh, comunque… in tutta la parte di conference prima delle domande e risposte…nessun cenno a Belinostat.


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